Data / Medical devices / Stimulator, Electro-Acupuncture
Stimulator, Electro-Acupuncture (BWK): 11 FDA-registered makers in 6 countries
11 establishments in 6 countries are registered with the FDA to make Stimulator, Electro-Acupuncture (product code BWK, Class U). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 24 510(k) clearances under this code, the latest on October 22, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- BWK
- Device class
- U
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| China | 2 |
| Japan | 2 |
| Switzerland | 2 |
| India | 1 |
| Hong Kong | 1 |
Makers of Stimulator, Electro-Acupuncture
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Wuxi Jiajian Medical Instrument Co., Ltd | Wuxi Jiangsu, China | Exporter to the US, Manufacturer | 4 | March 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Bozhou Rongjian Medical Appliance Co., Ltd. | Bozhou Anhui, China | Exporter to the US, Manufacturer | 1 | March 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| Ito Co., Ltd. | Kawaguchi Saitama, Japan | Specification developer | 1 | November 24, 2008 | 0 | 0 | 0 | api.fda.gov |
| ITO CO., LTD. Tsukuba Factory | Inashiki-Gun Ibaraki, Japan | Manufacturer | 1 | November 24, 2008 | 0 | 0 | 0 | api.fda.gov |
| Neuraxis, Inc | Carmel, IN, United States | Complaint file establishment, Specification developer | 1 | October 2, 2014 | 0 | 0 | 0 | api.fda.gov |
| North Coast Medical, Inc. | Morgan Hill, CA, United States | Manufacturer, Repackager or relabeler | 1 | August 27, 2021 | 0 | 0 | 0 | api.fda.gov |
| Neurostimulation Medtech Private Limited | Chennai Tamil Nadu, India | Manufacturer | 1 | March 9, 2017 | 0 | 0 | 0 | api.fda.gov |
| Tens Plus Industrial Co. | Hong Kong, Hong Kong | Manufacturer | 1 | February 3, 2021 | 0 | 0 | 0 | api.fda.gov |
| Frueh Verpackungstechnik AG | Fehraltorf Zurich, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gmi Corporation | Franklin, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Theia Holding SA | La Chaux-de-Fonds Neuchatel, Switzerland | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 22, 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.