FDA 510(k) Applications for Medical Device Product Code "BWK"
(Stimulator, Electro-Acupuncture)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K140788 | BIEGLER GMBH | P-STIM | 06/27/2014 |
| K152571 | BIEGLER GMBH | Stivax | 05/26/2016 |
| K220153 | Bozhou Rongjian Medical Appliance Co.,Ltd. | Needle Stimulator (Model: RJNS6-1) | 03/18/2022 |
| K170391 | DyAnsys Inc | ANSiStim-PP | 03/09/2017 |
| K141168 | DYANSYS, INC. | ANSISTIM | 05/15/2015 |
| K051197 | INNO-HEALTH TECHNOLOGY, INC. | ACULIFE, MODEL SMW-01 | 03/28/2006 |
| K091933 | INNO-HEALTH TECHNOLOGY, INC. | ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01 | 04/02/2010 |
| K081943 | ITO CO., LTD. | MODEL ES-130 | 11/24/2008 |
| K200636 | Lhasa OMS, INC. | AXUS ES-5 Electro-Acupuncture Device | 02/03/2021 |
| K091875 | MEDEVICE CORPORATION | E-PULSE | 12/07/2009 |
| K140530 | NAVIGANT CONSULTING, INC. | Electro Auricular Device | 10/02/2014 |
| K050123 | NEUROSCIENCE THERAPY CORP. | P-STIM SYSTEM | 03/30/2006 |
| K133980 | PANTHEON RESEARCH | PANTHEON ELECTROSTIMULATOR | 11/07/2014 |
| K014273 | S.H.P. INTL. PTY., LTD. | ACUSTIM | 06/12/2002 |
| K093322 | UPC MEDICAL SUPPLIES, INC. DBA UNITED PACIFIC CO. | MULTI-PURPOSE HEALTH DEVICE | 08/05/2010 |
| K202861 | Wuxi Jiajian Medical Instrument Co., Ltd | Needle Stimulator | 08/27/2021 |
| K130768 | WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. | JIAJIAN CMN STIMULATOR | 08/16/2013 |
| K122812 | WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. | JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS | 04/11/2013 |
| K244030 | Wuxi Jiajian Medical Instrument Co., Ltd. | Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) | 03/28/2025 |
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