Product code BWK
- Device name
- Stimulator, Electro-Acupuncture
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K244030 | Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2025-03-28 |
| K220153 | Needle Stimulator (Model: RJNS6-1) | Bozhou Rongjian Medical Appliance Co., Ltd. | 2022-03-18 |
| K202861 | Needle Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | 2021-08-27 |
| K200636 | AXUS ES-5 Electro-Acupuncture Device | Lhasa Oms, Inc. | 2021-02-03 |
| K170391 | ANSiStim-PP | Dyansys, Inc. | 2017-03-09 |
| K152571 | Stivax | Biegler GmbH | 2016-05-26 |
| K141168 | ANSISTIM | Dyansys, Inc. | 2015-05-15 |
| K133980 | PANTHEON ELECTROSTIMULATOR | Pantheon Research | 2014-11-07 |
| K140530 | Electro Auricular Device | Navigant Consulting, Inc. | 2014-10-02 |
| K140788 | P-STIM | Biegler GmbH | 2014-06-27 |
| K130768 | JIAJIAN CMN STIMULATOR | Wuxi Jiajian Medical Instrument Co., Ltd. | 2013-08-16 |
| K122812 | JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS | Wuxi Jiajian Medical Instrument Co., Ltd. | 2013-04-11 |
| K093322 | MULTI-PURPOSE HEALTH DEVICE | Upc Medical Supplies, Inc. Dba United Pacific Co. | 2010-08-05 |
| K091933 | ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01 | Inno-Health Technology, Inc. | 2010-04-02 |
| K091875 | E-PULSE | Medevice Corporation | 2009-12-07 |
| K081943 | MODEL ES-130 | Ito Co., Ltd. | 2008-11-24 |
| K050123 | P-STIM SYSTEM | Neuroscience Therapy Corp. | 2006-03-30 |
| K051197 | ACULIFE, MODEL SMW-01 | Inno-Health Technology, Inc. | 2006-03-28 |
| K014273 | ACUSTIM | S.H.P. Intl. Pty., Ltd. | 2002-06-12 |
| K840983 | PULSELIFE STIMULATOR | Pulse Life, Inc. | 1984-03-27 |
| K840995 | ACUPUNCTURE INSOLES | Lu LU Enterprise Co. , Ltd. | 1984-03-27 |
| K832634 | SELECTRODE SYSTEM | Bio-Stimu Trend Corp. | 1984-01-25 |
| K781651 | HEALTH POINT | Anritsu America Co. | 1979-04-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00768627017152 | Blue Diamond 360 Needle Stimulator Lead Wires - Alligator Clip | NORTH COAST MEDICAL, INC. | 2026-06-01 |
| 00768627017169 | Blue Diamond 360 Needle Stimulator Lead Wires - Pigtail | NORTH COAST MEDICAL, INC. | 2026-06-01 |
| 00768627017145 | Blue Diamond 360 Needle Stimulator | NORTH COAST MEDICAL, INC. | 2026-06-01 |
| 06973774194265 | QIJIU | Bozhou Rongjian Medical Appliance Co., Ltd. | 2026-04-03 |
| 08908006064281 | ANSiSTIM-PP | NEUROSTIMULATION MEDTECH PRIVATE LIMITED | 2026-03-16 |
| 06932307410395 | JIAJIAN | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2026-03-04 |
| 06932307410401 | JIAJIAN | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2026-03-04 |
| 06932307410449 | JIAJIAN | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2026-03-04 |
| 06932307410456 | JIAJIAN | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2026-03-04 |
| 06972011718424 | JIAJIAN | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2026-03-03 |
| 06972011718431 | JIAJIAN | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2026-03-03 |
| 04719874910013 | Aculife | INNO HEALTH TECHNOLOGY CO., LTD. | 2024-03-26 |
| 14897076722812 | SEARCH+STIM PROBE AXUS ES-5 | TENS PLUS INDUSTRIAL COMPANY | 2022-11-14 |
| 14897076720092 | AXUS ES-5 | TENS PLUS INDUSTRIAL COMPANY | 2021-03-30 |
| B960NSS201 | NSS NeuroStim | Neuraxis, Inc. | 2020-11-09 |
| B327NSS201 | NSS Neurostim | KEY ELECTRONICS, INC. | 2019-03-22 |
| B327NSS202 | NSS MFS | KEY ELECTRONICS, INC. | 2019-03-22 |
| 74719874910005 | Aculife | INNO HEALTH TECHNOLOGY CO., LTD. | 2018-11-27 |
| 00810011252509 | Jiajian | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2018-11-26 |
| 08150050225006 | Jiajian | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2016-10-21 |
| 10815005022400 | Jiajian | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2016-10-21 |
| 04983087008403 | ES-130 | ITO CO., LTD. | 2016-09-24 |
| 00831592004196 | Yingdi Multi Purpose Health Device | UPC MEDICAL SUPPLIES, INC. | 2016-09-23 |
| 00831592004202 | Yingdi Multi Purpose Health Device | UPC MEDICAL SUPPLIES, INC. | 2016-09-23 |
| 00831592004219 | Yingdi Multi Purpose Health Device | UPC MEDICAL SUPPLIES, INC. | 2016-09-23 |