# FDA Physical Medicine device clearances: 272 since Nov 2024

Updated October 30, 2026.

FDA made 272 device decisions in physical medicine (FDA review panel) from November 12, 2024 to October 30, 2026: 261 510(k) clearances and De Novo grants and 11 PMA approvals and supplements, for 184 applicants. The newest, K262470 on October 30, 2026, is Dual-Channel TENS & EMS Muscle Stimulator (Models TS1111, TS4111) from Changsha Anxiang Medical Technology Co., Ltd..

## The full list

FDA physical medicine device clearances and approvals: 272 rows for $13.60, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. Columns: Number, Pathway, Device name, Applicant, Applicant address, Contact, Decision, Decision date, Decision type, Date received, Product code, Device type, Device class, Panel, Applicant state, Applicant country, Supplement reason, Read on, Source. The new rows each week by email, about 12 rows a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, date received, device type and 6 more), which open on your screen as soon as the payment clears and come by email. The rows on this page are a sample.

Buy: https://specstream.ai/data/fda-clearances/panel/physical-medicine

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

- Decisions: 272
- 510(k) and De Novo: 261
- PMA: 11
- Latest decision: October 30, 2026

## Newest decisions

The newest 100 of 272, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

| Decision date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| October 30, 2026 | K262470 | Dual-Channel TENS & EMS Muscle Stimulator (Models TS1111, TS4111) | Changsha Anxiang Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | NGX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262470) |
| October 28, 2026 | K263313 | Red Light Therapy Hair Growth Cap (RB-009, RB-011, RB-012, RB-088, RB-089, RB-092) | Shenzhen Rainbow Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | OAP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263313) |
| October 28, 2026 | K263005 | Electric wheelchair (LW01301A02/LW01301A02L/LW01301A02T) | Anhui Longway Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263005) |
| October 26, 2026 | K261156 | Power Wheelchair (DC07, DC07M, DC08M, DC09F, DC10M) | Anhui JBH Medical Apparatus Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261156) |
| October 26, 2026 | K261155 | Power Wheelchair (DC07A, DC07S, DC08A, DC08S, DC09, DC09A, DC09S, DC09M, DC10A, DC10S) | Anhui JBH Medical Apparatus Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261155) |
| October 14, 2026 | K261169 | Power Wheelchair (D39) | Anhui JBH Medical Apparatus Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261169) |
| October 13, 2026 | K263257 | Electrically Powered Wheelchair (YC-01) | Yurob Rehabilitation Medical Co., Ltd. | China | Substantially Equivalent | 510(k) special | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263257) |
| October 13, 2026 | K262652 | Electric Wheelchair (CN501) | Zhejiang Shimo Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262652) |
| October 9, 2026 | K262834 | Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615... | Shenzhen Jianchao Intelligent Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | OAP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262834) |
| October 6, 2026 | K261887 | Normatec Elite Heat (PRO26-SH);Normatec Elite Heat (PRO26-ST);Normatec Elite Heat (PRO26-TL);Normatec Elite... | NormaTec Industries, LP | Massachusetts | Substantially Equivalent | 510(k) traditional | IRP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261887) |
| October 6, 2026 | K261200 | Power Wheelchair (D60) | Anhui JBH Medical Apparatus Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261200) |
| October 6, 2026 | K261079 | Power Wheelchair (DC12) | Anhui JBH Medical Apparatus Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261079) |
| October 5, 2026 | K262812 | Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1... | Sichuan Qianli-Beoka Medical Technology, Inc. | China | Substantially Equivalent | 510(k) traditional | IRP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262812) |
| September 29, 2026 | K262553 | MOBILITY SCOOTER (YQ-401,YQ- 401A,YQ-403,YQ-403A) | Zhejiang Kailang Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | INI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262553) |
| September 29, 2026 | K262241 | Electric Wheelchair (0080) | Xuzhou Heabens Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262241) |
| September 29, 2026 | K262213 | Power Mobility Scooter (MA03) | Nanjing Mijo Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | INI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262213) |
| September 24, 2026 | K262183 | Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60) | Shenzhen Nuon Medical Equipment Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | OAP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262183) |
| September 24, 2026 | K261078 | Electric Scooter (FNS01,FNS03) | Anhui Jbh Medical Apparatus Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | INI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261078) |
| September 23, 2026 | K262582 | Electric wheelchair (GP100) | Suzhou Green Pine Medical Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262582) |
| September 23, 2026 | K262254 | Hair Growth Comb (X-GC01) | Guangdong Ashmore Health Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | OAP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262254) |
| September 22, 2026 | K253762 | ErgoSteel (ES0001/696) | Strongback Mobility AG C/O Blueaudit GmbH | Switzerland | Substantially Equivalent | 510(k) traditional | IOR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253762) |
| September 19, 2026 | K261859 | Electric Scooter (FDB08, FDB08A, FDB12) | Anhui JBH Medical Apparatus Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | INI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261859) |
| September 16, 2026 | P210007/S015 | Vivistim® System | Mobia Medical, Inc. | Texas | 30-day notice accepted | PMA 30-day notice | QPY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210007S015) |
| September 16, 2026 | K262054 | Electric Wheelchair | Yongkang Joymax Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262054) |
| September 16, 2026 | K261919 | Multifunctional wheelchair (YJ-059) | Zhenjiang Assure Medical Equipment Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | IOR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261919) |
| September 15, 2026 | K260145 | YJ-K1K2 Wheelchair (YJ-013F) | Zhenjiang Assure Medical Equipment Co., Ltd. | China | Substantially Equivalent | 510(k) special | IOR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260145) |
| September 15, 2026 | K260144 | Reclining wheelchair (YJ-013L) | Zhenjiang Assure Medical Equipment Co., Ltd. | China | Substantially Equivalent | 510(k) special | IOR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260144) |
| September 15, 2026 | K260141 | Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C) | Zhenjiang Assure Medical Equipment Co., Ltd. | China | Substantially Equivalent | 510(k) special | IOR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260141) |
| September 8, 2026 | K260229 | Electric wheelchair (HC819N, HC830N, HC831N) | Yongkang Hengyi Vehicle Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260229) |
| September 8, 2026 | K260053 | Power Wheelchair (OS-R-M01I) | Beijing OrionStar Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260053) |
| September 2, 2026 | K254198 | Trexo Theo | Trexo Robotics, Inc. | Canada | Substantially Equivalent | 510(k) traditional | PHL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254198) |
| August 31, 2026 | K262788 | Nova HD+ | Aura Wellness, LLC | Kentucky | Substantially Equivalent | 510(k) special | SGT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262788) |
| August 21, 2026 | K261354 | Electric wheelchair (D03) | Foshan Sowell Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261354) |
| August 13, 2026 | K253790 | High Intensity Focused Electromagnetic Stimulation Device (FE60) | Beijing Winkonlaser Technology Limited | China | Substantially Equivalent | 510(k) traditional | NGX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253790) |
| August 12, 2026 | K260944 | ManaCold Compression System | Manamed, LLC | Texas | Substantially Equivalent | 510(k) traditional | IRP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260944) |
| August 10, 2026 | K260176 | Mobility Scooter (W3483, W3483A) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | China | Substantially Equivalent | 510(k) traditional | INI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260176) |
| August 10, 2026 | K260094 | Mobility Scooter (W3465, W3902 (S50 Carbon)) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | China | Substantially Equivalent | 510(k) traditional | INI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260094) |
| August 6, 2026 | K261571 | Manual Wheelchair (H008, PCK7) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | IOR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261571) |
| August 3, 2026 | K260381 | Eve | Wandercraft SAS | France | Substantially Equivalent | 510(k) traditional | PHL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260381) |
| July 27, 2026 | K260529 | Air Compression Massager (HY-1165) | Xiamen High Top Electronic Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | IRP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260529) |
| July 27, 2026 | K250419 | Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature... | Plus EV Holdings, Inc. D/B/A Intimate Rose | Missouri | Substantially Equivalent | 510(k) traditional | OSD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250419) |
| July 24, 2026 | K260948 | Air Compression Massager (EP30B001 I) | Wavepulse (Xiamen) Healthcare Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | IRP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260948) |
| July 24, 2026 | K252370 | GEN 4 JOY Wheelchair | Free Wheelchair Mission | California | Substantially Equivalent | 510(k) traditional | IOR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252370) |
| July 17, 2026 | K261675 | CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) | Shenzhen Chuanghong Zhilian Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | OAP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261675) |
| July 14, 2026 | K261232 | IERO Mobility Scooter (IERO-01) | Jochu Technology Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | INI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261232) |
| July 10, 2026 | K261149 | Electric Wheelchair (DY611A-2, DY612A-1) | Zhejiang Lumbre Electric Appliance Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261149) |
| July 8, 2026 | K261396 | Electric Wheelchair | Ningbo Resshidi Medical Devices Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261396) |
| July 7, 2026 | K261164 | Electric wheelchair (XW-LY007 ) | Yongkang Ruihe Metal Product Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261164) |
| July 7, 2026 | K261163 | Mobility Scooter (R200) | Yongkang Ruihe Metal Product Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | INI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261163) |
| June 26, 2026 | K261253 | Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1... | Ziree Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | OAP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261253) |
| June 24, 2026 | K260937 | Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) | Shanghai Waylong Intelligent Technology Co.,Ltd | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260937) |
| June 22, 2026 | K261076 | Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | IOR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261076) |
| June 22, 2026 | K261075 | Manual Wheelchair (MS01);Manual Wheelchair (MA01) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | IOR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261075) |
| June 18, 2026 | P210007/S014 | Vivistim Pair VNS System | Mobia Medical, Inc. | Texas | 30-day notice accepted | PMA 30-day notice | QPY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210007S014) |
| June 18, 2026 | K253812 | Power Wheelchair (W5915B, W5915C, W5915D) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253812) |
| June 16, 2026 | K260899 | Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) | Zdeer Technology (Henan) Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | OAP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260899) |
| June 16, 2026 | K253231 | Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet... | Hubei Yjt Technology Co.,Ltd | China | Substantially Equivalent | 510(k) traditional | OAP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253231) |
| June 15, 2026 | K260335 | Electric Wheelchair (S500-6) | Zhongshan Sulenz Intelligent Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260335) |
| June 12, 2026 | K261175 | WHILL (WHILL Model C2) | Whill, Inc. | Japan | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261175) |
| June 12, 2026 | K252963 | BTL-899TT | BTL Industries, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | IMJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252963) |
| June 11, 2026 | K260849 | ICON 35; ICON 45; ICON 60; ICON 30FAF | Rehasense USA, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | IOR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260849) |
| June 10, 2026 | K253919 | Cryo And Thermo Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | IRP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253919) |
| June 8, 2026 | K253542 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | South Korea | Substantially Equivalent | 510(k) traditional | IPF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253542) |
| June 8, 2026 | K253257 | Virgo Mobility Scooter (Virgo-D,Virgo-F) | Jiangsu Intco Medical Products Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | INI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253257) |
| June 5, 2026 | K260056 | Power Wheelchair (N5515A, N5516, N5517A, N5519) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260056) |
| June 5, 2026 | K251684 | Alma TED+ System | Alma Lasers, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | OAP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251684) |
| June 3, 2026 | K260373 | Electric Wheelchair (DF506) | Jiangsu Yveelt Medical Equipment Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260373) |
| June 3, 2026 | K253600 | Scooter (YD-03) | Yurob Rehabilitation Medical Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | INI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253600) |
| June 2, 2026 | K260642 | Manual Wheelchair (LW01108) | Anhui Longway Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | IOR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260642) |
| June 2, 2026 | K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP) | Mohammadali Nezakati | California | Substantially Equivalent | 510(k) traditional | IPF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252816) |
| May 29, 2026 | K252396 | Cryo Sport 2.0 (AVA 501) | Avanutri Equipamentos DE Saúde | Brazil | Substantially Equivalent | 510(k) traditional | IRP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252396) |
| May 28, 2026 | K260295 | Helio Kids; Apex P | Motion Composites | Canada | Substantially Equivalent | 510(k) traditional | IOR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260295) |
| May 27, 2026 | K260142 | StimelMD (SSMD) system | Motion Informatics ltd. | Israel | Substantially Equivalent | 510(k) special | IPF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260142) |
| May 21, 2026 | K254141 | Manual Wheelchair (DY01903(2)) | Guangdong Dayang Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | IOR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254141) |
| May 20, 2026 | K260717 | Mobility Scooter (Air Carbon) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | INI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260717) |
| May 19, 2026 | K254024 | MR5 Activ Pro | Multi Radiance Medical, Inc. | Ohio | Substantially Equivalent | 510(k) traditional | NHN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254024) |
| May 13, 2026 | K253241 | Electric Wheelchair (Y207BL) | Jiangsu Intco Medical Products Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253241) |
| May 5, 2026 | K254200 | Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1... | Wenzhou Lingfeng Electronic Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | IRP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254200) |
| April 30, 2026 | K253064 | Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System... | Xiamen Weiyou Intelligent Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | IRP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253064) |
| April 28, 2026 | K260121 | Manual Wheelchair (7101L, 7102LHD) | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | IOR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260121) |
| April 28, 2026 | K260076 | SAM 3.0 Multi-Hour Continuous Ultrasound Device | ZetrOZ Systems, LLC | Connecticut | Substantially Equivalent | 510(k) special | PFW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260076) |
| April 22, 2026 | K260237 | Mobility Scooter (X-12, X-14, X-17) | Wuyi Aichi Industry and Trade Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | INI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260237) |
| April 20, 2026 | K253806 | Power Wheelchair (N5919 series) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | China | Substantially Equivalent | 510(k) special | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253806) |
| April 20, 2026 | K253638 | xStep (xStep) | Spinex, Inc. | California | Substantially Equivalent | 510(k) traditional | SDO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253638) |
| April 10, 2026 | P210007/S013 | Vivistim® System | Mobia Medical, Inc. | Texas | 30-day notice accepted | PMA 30-day notice | QPY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210007S013) |
| April 10, 2026 | K253926 | Diacore | ShenB Co., Ltd. | South Korea | Substantially Equivalent | 510(k) traditional | NGX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253926) |
| April 7, 2026 | K253952 | Power Wheelchair (OS-R-M01S) | Beijing OrionStar Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253952) |
| April 3, 2026 | K253340 | Electric Wheelchair (AL-208S-063) | Zhongshan A&J Medical Equipment Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253340) |
| April 3, 2026 | K252386 | Hot and Cold Compression System (A02-C-032) | Chengdu Cryo-Push Medical Technology Co.,Ltd | China | Substantially Equivalent | 510(k) traditional | IRP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252386) |
| April 2, 2026 | K253076 | Cryopush Cold Compression Device (A02-P-001) | Chengdu Cryo-Push Medical Technology Co.,Ltd | China | Substantially Equivalent | 510(k) traditional | IRP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253076) |
| April 1, 2026 | P210007/S012 | Vivistim® Paired VNS™ System | Mobia Medical, Inc. | Texas | 30-day notice accepted | PMA 30-day notice | QPY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210007S012) |
| March 31, 2026 | K260319 | K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16”... | Zhenjiang Assure Medical Equipment Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | IOR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260319) |
| March 27, 2026 | K254206 | Power wheelchair (ZS-EW8026) | Ningbo Zhishan Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254206) |
| March 27, 2026 | K253980 | Electrically Powered Wheelchair (Model YC-01) | Yurob Rehabilitation Medical Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253980) |
| March 27, 2026 | K253307 | Electric wheelchair | Foshan Dahao Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253307) |
| March 27, 2026 | K252893 | ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad... | Aneuvo | California | Substantially Equivalent | 510(k) traditional | SDO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252893) |
| March 24, 2026 | K254012 | Electric Wheelchair (E201) | Nanjing CareMoving Rehabilitation Equipment Co.,Ltd | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254012) |
| March 20, 2026 | K253849 | Electric wheelchair (JJW-7002, JJW-7003) | ZheJiang J&J Mobility Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253849) |
| March 19, 2026 | K253965 | CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight... | Wuhan PHOMED Technology Company , Ltd. | China | Substantially Equivalent | 510(k) traditional | ILY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253965) |
| March 19, 2026 | K252101 | JWG-1 | Yamaha Motor Co., Ltd. | Japan | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252101) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Mobia Medical, Inc. | 11 | September 16, 2026 |
| Changsha Anxiang Medical Technology Co., Ltd. | 6 | October 30, 2026 |
| Anhui JBH Medical Apparatus Co., Ltd. | 6 | October 26, 2026 |
| Anhui Jbh Medical Apparatus Co., Ltd. | 6 | September 24, 2026 |
| Zhenjiang Assure Medical Equipment Co., Ltd. | 6 | September 16, 2026 |
| Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 6 | August 10, 2026 |
| Xiamen Weiyou Intelligent Technology Co., Ltd. | 4 | June 10, 2026 |
| Suzhou Master Machinery Manufacturing Co.,Ltd | 4 | March 4, 2026 |
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | 4 | January 23, 2026 |
| Anhui Longway Medical Technology Co., Ltd. | 3 | October 28, 2026 |
| Yurob Rehabilitation Medical Co., Ltd. | 3 | October 13, 2026 |
| Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 3 | January 29, 2026 |
| Zhejiang Nysin Medical Co., Ltd. | 3 | January 29, 2026 |
| Intradin (Shanghai) Machinery Co., Ltd. | 3 | November 21, 2025 |
| Ceragem Co., Ltd. | 3 | July 11, 2025 |
| Kunshan Hi-Fortune Health Products Co., Ltd. | 3 | March 26, 2025 |
| NormaTec Industries, LP | 2 | October 6, 2026 |
| Sichuan Qianli-Beoka Medical Technology, Inc. | 2 | October 5, 2026 |
| Nanjing Mijo Technology Co., Ltd. | 2 | September 29, 2026 |
| Yongkang Hengyi Vehicle Co., Ltd. | 2 | September 8, 2026 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 233 | October 30, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 24 | October 13, 2026 |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 9 | September 16, 2026 |
| [De Novo](https://specstream.ai/data/fda-clearances/decision/de-novo) | 3 | January 16, 2026 |
| [PMA 180-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-180-day-supplement) | 2 | February 26, 2026 |
| [510(k) abbreviated](https://specstream.ai/data/fda-clearances/decision/510k-abbreviated) | 1 | December 19, 2024 |

## By state or country

| State or country | Decisions | Latest |
| --- | --- | --- |
| [China](https://specstream.ai/data/fda-clearances/country/china) | 175 | October 30, 2026 |
| [Texas](https://specstream.ai/data/fda-clearances/state/texas) | 12 | September 16, 2026 |
| [Massachusetts](https://specstream.ai/data/fda-clearances/state/massachusetts) | 6 | October 6, 2026 |
| [South Korea](https://specstream.ai/data/fda-clearances/country/south-korea) | 6 | June 8, 2026 |
| [California](https://specstream.ai/data/fda-clearances/state/california) | 5 | July 24, 2026 |
| [Israel](https://specstream.ai/data/fda-clearances/country/israel) | 5 | May 27, 2026 |
| [Netherlands](https://specstream.ai/data/fda-clearances/country/netherlands) | 5 | March 15, 2026 |
| [Canada](https://specstream.ai/data/fda-clearances/country/canada) | 4 | September 2, 2026 |
| [France](https://specstream.ai/data/fda-clearances/country/france) | 3 | August 3, 2026 |
| [Taiwan](https://specstream.ai/data/fda-clearances/country/taiwan) | 3 | July 14, 2026 |
| [Japan](https://specstream.ai/data/fda-clearances/country/japan) | 3 | June 12, 2026 |
| [Brazil](https://specstream.ai/data/fda-clearances/country/brazil) | 3 | May 29, 2026 |
| [Spain](https://specstream.ai/data/fda-clearances/country/spain) | 3 | March 12, 2026 |
| [Germany](https://specstream.ai/data/fda-clearances/country/germany) | 3 | January 16, 2026 |
| [Florida](https://specstream.ai/data/fda-clearances/state/florida) | 3 | July 18, 2025 |
| Kentucky | 2 | August 31, 2026 |
| [Illinois](https://specstream.ai/data/fda-clearances/state/illinois) | 2 | June 11, 2026 |
| [Pennsylvania](https://specstream.ai/data/fda-clearances/state/pennsylvania) | 2 | November 5, 2025 |
| [Austria](https://specstream.ai/data/fda-clearances/country/austria) | 2 | April 11, 2025 |
| [Switzerland](https://specstream.ai/data/fda-clearances/country/switzerland) | 1 | September 22, 2026 |
| [Missouri](https://specstream.ai/data/fda-clearances/state/missouri) | 1 | July 27, 2026 |
| [Ohio](https://specstream.ai/data/fda-clearances/state/ohio) | 1 | May 19, 2026 |
| [Connecticut](https://specstream.ai/data/fda-clearances/state/connecticut) | 1 | April 28, 2026 |
| South Carolina | 1 | February 19, 2026 |
| [Colorado](https://specstream.ai/data/fda-clearances/state/colorado) | 1 | January 16, 2026 |

## Where FDA publishes these decisions

- [FDA 510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)
- [FDA PMA database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm)
- [openFDA device API](https://open.fda.gov/apis/device/)

Source: [openFDA device 510(k) and PMA (U.S. Food and Drug Administration)](https://open.fda.gov/apis/device/). CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission.

Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).