Product code BWK ยท Class U
Stimulator, Electro-Acupuncture
1510(k)s in 12 months (24 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in BWK
| Company | 510(k)s | Recalls |
|---|---|---|
| Wuxi Jiajian Medical Instrument Co., Ltd. | 4 | 0 |
| Biegler GmbH | 2 | 0 |
| Dyansys, Inc. | 2 | 0 |
| Inno-Health Technology, Inc. | 2 | 0 |
| Anritsu America Co. | 1 | 0 |
| Bio-Stimu Trend Corp. | 1 | 0 |
| Bozhou Rongjian Medical Appliance Co., Ltd. | 1 | 0 |
| Ito Co., Ltd. | 1 | 0 |
| Lhasa Oms, Inc. | 1 | 0 |
| Lu LU Enterprise Co. , Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 22, 2026 | K260230 | Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) Suzhou Medical Appliance Factory, CN | BWK |
| Mar 28, 2025 | K244030 | Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) Wuxi Jiajian Medical Instrument Co., Ltd., CN | BWK |
| Mar 18, 2022 | K220153 | Needle Stimulator (Model: RJNS6-1) Bozhou Rongjian Medical Appliance Co., Ltd., CN | BWK |
| Aug 27, 2021 | K202861 | Needle Stimulator Wuxi Jiajian Medical Instrument Co., Ltd., CN | BWK |
| Feb 3, 2021 | K200636 | AXUS ES-5 Electro-Acupuncture Device Lhasa Oms, Inc. | BWK |
| Mar 9, 2017 | K170391 | ANSiStim-PP Dyansys, Inc. | BWK |
| May 26, 2016 | K152571 | Stivax Biegler GmbH, AT | BWK |
| May 15, 2015 | K141168 | ANSISTIM Dyansys, Inc. | BWK |
| Nov 7, 2014 | K133980 | PANTHEON ELECTROSTIMULATOR Pantheon Research | BWK |
| Oct 2, 2014 | K140530 | Electro Auricular Device Navigant Consulting, Inc. | BWK |
| Jun 27, 2014 | K140788 | P-STIM Biegler GmbH | BWK |
| Aug 16, 2013 | K130768 | JIAJIAN CMN STIMULATOR Wuxi Jiajian Medical Instrument Co., Ltd., CN | BWK |
| Apr 11, 2013 | K122812 | JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS Wuxi Jiajian Medical Instrument Co., Ltd., CN | BWK |
| Aug 5, 2010 | K093322 | MULTI-PURPOSE HEALTH DEVICE Upc Medical Supplies, Inc. Dba United Pacific Co. | BWK |
| Apr 2, 2010 | K091933 | ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01 Inno-Health Technology, Inc., TW | BWK |
| Dec 7, 2009 | K091875 | E-PULSE Medevice Corporation | BWK |
| Nov 24, 2008 | K081943 | MODEL ES-130 Ito Co., Ltd. | BWK |
| Mar 30, 2006 | K050123 | P-STIM SYSTEM Neuroscience Therapy Corp. | BWK |
| Mar 28, 2006 | K051197 | ACULIFE, MODEL SMW-01 Inno-Health Technology, Inc., TW | BWK |
| Jun 12, 2002 | K014273 | ACUSTIM S.H.P. Intl. Pty., Ltd., AU | BWK |
| Mar 27, 1984 | K840995 | ACUPUNCTURE INSOLES Lu LU Enterprise Co. , Ltd. | BWK |
| Mar 27, 1984 | K840983 | PULSELIFE STIMULATOR Pulse Life, Inc. | BWK |
| Jan 25, 1984 | K832634 | SELECTRODE SYSTEM Bio-Stimu Trend Corp. | BWK |
| Apr 3, 1979 | K781651 | HEALTH POINT Anritsu America Co. | BWK |
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