Data / Medical devices / China / Hong Qiangxing (shen Zhen) Electronics Limited
Hong Qiangxing (shen Zhen) Electronics Limited: FDA-registered device maker in Shenzhen Guangdong, China, 13 510(k) clearances
Hong Qiangxing (shen Zhen) Electronics Limited is registered with the FDA (registration 3010402752) in Shenzhen Guangdong, China. It lists 19 device types. The FDA files 13 510(k) clearances under its listings, the newest dated October 16, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010402752
- Address
- 2F, Yongcheng Blvd, Xicheng Industrial Zone Xixiang Street, Bao'an District, Shenzhen Guangdong, China, 518126
- Owner or operator
- Hong Qiangxing (Shen Zhen) Electronics Limited (10044280)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- May 20, 2013
- Registered through
- 2027
- Brand names listed
- AIO I-QC, Abs NRG, Archer Dual Stim Touch, Belifu TENS001, CACI MICRO-PRO (Model: SM9592), Crampology Relief Pink, Criterion®, Cycrorelax and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 16, 2026 | K261574 | Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) | NUH | Substantially Equivalent | Hong Qiangxing (Shenzhen) Electronics Limited | accessdata.fda.gov |
| December 23, 2025 | K253740 | TENS&EMS (HZ9151B, HZ9151C, HZ9151D) | NUH | Substantially Equivalent | Hong Qiangxing (Shenzhen) Electronics Limited | accessdata.fda.gov |
| November 22, 2024 | K243334 | Nooro Body & Foot Stimulator (SM9141, SM9142) | NUH | Substantially Equivalent | Xf Agencija Limited | accessdata.fda.gov |
| July 19, 2024 | K233067 | Wireless TENS & EMS (Model SM9110,SM9113,SM9116) | NUH | Substantially Equivalent | Chongqing Rob Linka Science and Technology Co., Ltd. | accessdata.fda.gov |
| February 12, 2024 | K233092 | Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) | NUH | Substantially Equivalent | Chongqing Rob Linka Science and Technology Co., Ltd. | accessdata.fda.gov |
| May 2, 2022 | K220283 | TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) | NUH | Substantially Equivalent | Hong Qiangxing (Shenzhen) Electronics Limited | accessdata.fda.gov |
| April 19, 2022 | K220152 | TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) | NUH | Substantially Equivalent | Hong Qiangxing (Shenzhen) Electronics Limited | accessdata.fda.gov |
| February 17, 2022 | K220150 | TENS & PMS (Model: SM9126) | NUH | Substantially Equivalent | Hong Qiangxing (Shenzhen) Electronics Limited | accessdata.fda.gov |
| December 11, 2020 | K201354 | TENS & PMS | NGX | Substantially Equivalent | Hong Qiangxing (Shenzhen) Electronics Limited | accessdata.fda.gov |
| December 2, 2019 | K190009 | Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) | NUH | Substantially Equivalent | Hong Qiangxing (Shenzhen) Electronics Limited | accessdata.fda.gov |
| March 26, 2019 | K183154 | SM Electrodes | GXY | Substantially Equivalent | Hong Qiangxing (Shenzhen) Electronics Limited | accessdata.fda.gov |
| August 5, 2014 | K133108 | FIT BELT | NGX | Substantially Equivalent | Hong Qiangxing (Shenzhen) Electronics Limited | accessdata.fda.gov |
| May 10, 2013 | K121719 | SM TENS & PMS | NGX | Substantially Equivalent | Hong Qiangxing (Shenzhen) Electronics Limited | accessdata.fda.gov |
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Updated October 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. 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.