Data / FDA device clearances / Physical Medicine

FDA Physical Medicine device clearances: 272 since Nov 2024

Name: FDA physical medicine device clearances and approvals
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

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. The list gains about 12 rows a month. The new rows come each week by email, $19 a month.

Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (pathway, device name, applicant address, contact, date received, device type and 6 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery. The rows on this page are a sample.

For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/panel/physical-medicine, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 30, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

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 request: Every new FDA clearance or approval of a physical medicine device, with the applicant, its address and the product code. $10 of credit on sign-up, no card.

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272Decisions
261510(k) and De Novo
11PMA
October 30, 2026Latest decision

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
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
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
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
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
October 14, 2026	K261169	Power Wheelchair (D39)	Anhui JBH Medical Apparatus Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
October 13, 2026	K263257	Electrically Powered Wheelchair (YC-01)	Yurob Rehabilitation Medical Co., Ltd.	China	Substantially Equivalent	510(k) special	ITI	accessdata.fda.gov
October 13, 2026	K262652	Electric Wheelchair (CN501)	Zhejiang Shimo Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
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
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
October 6, 2026	K261200	Power Wheelchair (D60)	Anhui JBH Medical Apparatus Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
October 6, 2026	K261079	Power Wheelchair (DC12)	Anhui JBH Medical Apparatus Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
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
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
September 29, 2026	K262241	Electric Wheelchair (0080)	Xuzhou Heabens Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
September 29, 2026	K262213	Power Mobility Scooter (MA03)	Nanjing Mijo Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	INI	accessdata.fda.gov
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
September 24, 2026	K261078	Electric Scooter (FNS01,FNS03)	Anhui Jbh Medical Apparatus Co., Ltd.	China	Substantially Equivalent	510(k) traditional	INI	accessdata.fda.gov
September 23, 2026	K262582	Electric wheelchair (GP100)	Suzhou Green Pine Medical Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
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
September 22, 2026	K253762	ErgoSteel (ES0001/696)	Strongback Mobility AG C/O Blueaudit GmbH	Switzerland	Substantially Equivalent	510(k) traditional	IOR	accessdata.fda.gov
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
September 16, 2026	P210007/S015	Vivistim® System	Mobia Medical, Inc.	Texas	30-day notice accepted	PMA 30-day notice	QPY	accessdata.fda.gov
September 16, 2026	K262054	Electric Wheelchair	Yongkang Joymax Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
September 16, 2026	K261919	Multifunctional wheelchair (YJ-059)	Zhenjiang Assure Medical Equipment Co., Ltd.	China	Substantially Equivalent	510(k) traditional	IOR	accessdata.fda.gov
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
September 15, 2026	K260144	Reclining wheelchair (YJ-013L)	Zhenjiang Assure Medical Equipment Co., Ltd.	China	Substantially Equivalent	510(k) special	IOR	accessdata.fda.gov
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
September 8, 2026	K260229	Electric wheelchair (HC819N, HC830N, HC831N)	Yongkang Hengyi Vehicle Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
September 8, 2026	K260053	Power Wheelchair (OS-R-M01I)	Beijing OrionStar Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
September 2, 2026	K254198	Trexo Theo	Trexo Robotics, Inc.	Canada	Substantially Equivalent	510(k) traditional	PHL	accessdata.fda.gov
August 31, 2026	K262788	Nova HD+	Aura Wellness, LLC	Kentucky	Substantially Equivalent	510(k) special	SGT	accessdata.fda.gov
August 21, 2026	K261354	Electric wheelchair (D03)	Foshan Sowell Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
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
August 12, 2026	K260944	ManaCold Compression System	Manamed, LLC	Texas	Substantially Equivalent	510(k) traditional	IRP	accessdata.fda.gov
August 10, 2026	K260176	Mobility Scooter (W3483, W3483A)	Zhejiang Innuovo Rehabilitation Devices Co.,Ltd	China	Substantially Equivalent	510(k) traditional	INI	accessdata.fda.gov
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
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
August 3, 2026	K260381	Eve	Wandercraft SAS	France	Substantially Equivalent	510(k) traditional	PHL	accessdata.fda.gov
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
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
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
July 24, 2026	K252370	GEN 4 JOY Wheelchair	Free Wheelchair Mission	California	Substantially Equivalent	510(k) traditional	IOR	accessdata.fda.gov
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
July 14, 2026	K261232	IERO Mobility Scooter (IERO-01)	Jochu Technology Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	INI	accessdata.fda.gov
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
July 8, 2026	K261396	Electric Wheelchair	Ningbo Resshidi Medical Devices Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
July 7, 2026	K261164	Electric wheelchair (XW-LY007 )	Yongkang Ruihe Metal Product Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
July 7, 2026	K261163	Mobility Scooter (R200)	Yongkang Ruihe Metal Product Co., Ltd.	China	Substantially Equivalent	510(k) traditional	INI	accessdata.fda.gov
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
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
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
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
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
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
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
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
June 15, 2026	K260335	Electric Wheelchair (S500-6)	Zhongshan Sulenz Intelligent Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
June 12, 2026	K261175	WHILL (WHILL Model C2)	Whill, Inc.	Japan	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
June 12, 2026	K252963	BTL-899TT	BTL Industries, Inc.	Massachusetts	Substantially Equivalent	510(k) traditional	IMJ	accessdata.fda.gov
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
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
June 8, 2026	K253542	Apollo Quattro (APQ-10M)	Weero Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	IPF	accessdata.fda.gov
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
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
June 5, 2026	K251684	Alma TED+ System	Alma Lasers, Inc.	Illinois	Substantially Equivalent	510(k) traditional	OAP	accessdata.fda.gov
June 3, 2026	K260373	Electric Wheelchair (DF506)	Jiangsu Yveelt Medical Equipment Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
June 3, 2026	K253600	Scooter (YD-03)	Yurob Rehabilitation Medical Co., Ltd.	China	Substantially Equivalent	510(k) traditional	INI	accessdata.fda.gov
June 2, 2026	K260642	Manual Wheelchair (LW01108)	Anhui Longway Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	IOR	accessdata.fda.gov
June 2, 2026	K252816	High Tone Power therapy (HiToP) (Model: HiToP PNP)	Mohammadali Nezakati	California	Substantially Equivalent	510(k) traditional	IPF	accessdata.fda.gov
May 29, 2026	K252396	Cryo Sport 2.0 (AVA 501)	Avanutri Equipamentos DE Saúde	Brazil	Substantially Equivalent	510(k) traditional	IRP	accessdata.fda.gov
May 28, 2026	K260295	Helio Kids; Apex P	Motion Composites	Canada	Substantially Equivalent	510(k) traditional	IOR	accessdata.fda.gov
May 27, 2026	K260142	StimelMD (SSMD) system	Motion Informatics ltd.	Israel	Substantially Equivalent	510(k) special	IPF	accessdata.fda.gov
May 21, 2026	K254141	Manual Wheelchair (DY01903(2))	Guangdong Dayang Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	IOR	accessdata.fda.gov
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
May 19, 2026	K254024	MR5 Activ Pro	Multi Radiance Medical, Inc.	Ohio	Substantially Equivalent	510(k) traditional	NHN	accessdata.fda.gov
May 13, 2026	K253241	Electric Wheelchair (Y207BL)	Jiangsu Intco Medical Products Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
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
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
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
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
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
April 20, 2026	K253806	Power Wheelchair (N5919 series)	Zhejiang Innuovo Rehabilitation Devices Co.,Ltd	China	Substantially Equivalent	510(k) special	ITI	accessdata.fda.gov
April 20, 2026	K253638	xStep (xStep)	Spinex, Inc.	California	Substantially Equivalent	510(k) traditional	SDO	accessdata.fda.gov
April 10, 2026	P210007/S013	Vivistim® System	Mobia Medical, Inc.	Texas	30-day notice accepted	PMA 30-day notice	QPY	accessdata.fda.gov
April 10, 2026	K253926	Diacore	ShenB Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	NGX	accessdata.fda.gov
April 7, 2026	K253952	Power Wheelchair (OS-R-M01S)	Beijing OrionStar Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
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
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
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
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
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
March 27, 2026	K254206	Power wheelchair (ZS-EW8026)	Ningbo Zhishan Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
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
March 27, 2026	K253307	Electric wheelchair	Foshan Dahao Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
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
March 24, 2026	K254012	Electric Wheelchair (E201)	Nanjing CareMoving Rehabilitation Equipment Co.,Ltd	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
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
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
March 19, 2026	K252101	JWG-1	Yamaha Motor Co., Ltd.	Japan	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov

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	233	October 30, 2026
510(k) special	24	October 13, 2026
PMA 30-day notice	9	September 16, 2026
De Novo	3	January 16, 2026
PMA 180-day supplement	2	February 26, 2026
510(k) abbreviated	1	December 19, 2024

By state or country

State or country	Decisions	Latest
China	175	October 30, 2026
Texas	12	September 16, 2026
Massachusetts	6	October 6, 2026
South Korea	6	June 8, 2026
California	5	July 24, 2026
Israel	5	May 27, 2026
Netherlands	5	March 15, 2026
Canada	4	September 2, 2026
France	3	August 3, 2026
Taiwan	3	July 14, 2026
Japan	3	June 12, 2026
Brazil	3	May 29, 2026
Spain	3	March 12, 2026
Germany	3	January 16, 2026
Florida	3	July 18, 2025
Kentucky	2	August 31, 2026
Illinois	2	June 11, 2026
Pennsylvania	2	November 5, 2025
Austria	2	April 11, 2025
Switzerland	1	September 22, 2026
Missouri	1	July 27, 2026
Ohio	1	May 19, 2026
Connecticut	1	April 28, 2026
South Carolina	1	February 19, 2026
Colorado	1	January 16, 2026

Where FDA publishes these decisions

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. Spot a wrong value? Write to [email protected] with the link to this page.