FDA product code BWK: Stimulator, Electro-Acupuncture
BWK is the FDA product code for stimulator, electro-acupuncture. It is a Unclassified device, reviewed by the Neurology panel. FDA has cleared 23 510(k) submissions under BWK, 2 in the last five years, from 17 different applicants. The average 510(k) review took 202 days (median 188); 88 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Electro-Acupuncture |
| Device class | Unclassified |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for BWK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 29 |
| 2021 | 2 | 332 |
| 2022 | 1 | 58 |
| 2025 | 1 | 88 |
Compare with all 510(k) review times · Search every BWK clearance
Top BWK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wuxi Jiajian Medical Instrument Co., Ltd. | 4 | 2025-03-28 |
| Dyansys, Inc. | 2 | 2017-03-09 |
| Biegler GmbH | 2 | 2016-05-26 |
| Inno-Health Technology, Inc. | 2 | 2010-04-02 |
| Bozhou Rongjian Medical Appliance Co., Ltd. | 1 | 2022-03-18 |
12 more applicants have BWK clearances. See the full list in Caduvo.
Most recent BWK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K244030 | Wuxi Jiajian Medical Instrument Co., Ltd. | Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) | 2025-03-28 | 88 |
| K220153 | Bozhou Rongjian Medical Appliance Co., Ltd. | Needle Stimulator (Model: RJNS6-1) | 2022-03-18 | 58 |
| K202861 | Wuxi Jiajian Medical Instrument Co., Ltd. | Needle Stimulator | 2021-08-27 | 333 |
| K200636 | Lhasa Oms, Inc. | AXUS ES-5 Electro-Acupuncture Device | 2021-02-03 | 330 |
| K170391 | Dyansys, Inc. | ANSiStim-PP | 2017-03-09 | 29 |
Recalls for BWK devices
openFDA lists no recalls for product code BWK.
Frequently asked questions
What is FDA product code BWK?
BWK is the FDA product code for stimulator, electro-acupuncture. It is a Unclassified device, reviewed by the Neurology panel.
What device class is BWK?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code BWK?
Across 23 cleared submissions the average was 202 days from receipt to decision (median 188).
Which companies have the most BWK clearances?
Wuxi Jiajian Medical Instrument Co., Ltd. (4); Dyansys, Inc. (2); Biegler GmbH (2); Inno-Health Technology, Inc. (2); Bozhou Rongjian Medical Appliance Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BWK
- Run a recall and safety report across every BWK manufacturer
- Watch product code BWK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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