BWK
23 FDA 510(k) clearances · Product code
188 daysmedian time to decision
333 days90th percentile
23clearances measured
FDA profile
- Official device name
- Stimulator, Electro-Acupuncture
- Device class
- Unclassified
- Medical specialty
- Unknown
- Adverse events (MAUDE)
- 1995: 1 · 2000: 1 · 2003: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) (K244030) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2025-03-28 |
| Needle Stimulator (Model: RJNS6-1) (K220153) | Bozhou Rongjian Medical Appliance Co., Ltd. | 2022-03-18 |
| Needle Stimulator (K202861) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2021-08-27 |
| AXUS ES-5 Electro-Acupuncture Device (K200636) | Lhasa Oms, Inc. | 2021-02-03 |
| ANSiStim-PP (K170391) | Dyansys, Inc. | 2017-03-09 |
| Stivax (K152571) | Biegler GmbH | 2016-05-26 |
| ANSISTIM (K141168) | Dyansys, Inc. | 2015-05-15 |
| PANTHEON ELECTROSTIMULATOR (K133980) | Pantheon Research | 2014-11-07 |
| Electro Auricular Device (K140530) | Navigant Consulting, Inc. | 2014-10-02 |
| P-STIM (K140788) | Biegler GmbH | 2014-06-27 |
| JIAJIAN CMN STIMULATOR (K130768) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2013-08-16 |
| JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS (K122812) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2013-04-11 |
| MULTI-PURPOSE HEALTH DEVICE (K093322) | Upc Medical Supplies, Inc. Dba United Pacific Co. | 2010-08-05 |
| ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01 (K091933) | Inno-Health Technology, Inc. | 2010-04-02 |
| E-PULSE (K091875) | Medevice Corporation | 2009-12-07 |
| MODEL ES-130 (K081943) | Ito Co., Ltd. | 2008-11-24 |
| P-STIM SYSTEM (K050123) | Neuroscience Therapy Corp. | 2006-03-30 |
| ACULIFE, MODEL SMW-01 (K051197) | Inno-Health Technology, Inc. | 2006-03-28 |
| ACUSTIM (K014273) | S.H.P. Intl. Pty., Ltd. | 2002-06-12 |
| ACUPUNCTURE INSOLES (K840995) | Lu LU Enterprise Co. , Ltd. | 1984-03-27 |
| PULSELIFE STIMULATOR (K840983) | Pulse Life, Inc. | 1984-03-27 |
| SELECTRODE SYSTEM (K832634) | Bio-Stimu Trend Corp. | 1984-01-25 |
| HEALTH POINT (K781651) | Anritsu America Co. | 1979-04-03 |
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Every clearance here is in the API, with alerts when new ones post.