Stimulator, Electro-Acupuncture
The Stimulator, Electro-Acupuncture is a device that delivers low-level electrical current through acupuncture needles to stimulate acupuncture points, used as a treatment in pain management and other therapeutic applications. Its FDA device class is currently unclassified; the device has not yet been formally categorized into Class 1, 2, or 3 and is awaiting classification action. The product code is BWK, with no assigned regulation number, reviewed by the Neurology panel.
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Basic Information
- Product Code
- BWK
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 23 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K244030 | Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) | Mar 28, 2025 | Substantially Equivalent | Wuxi Jiajian Medical Instrument Co., Ltd. |
| K220153 | Needle Stimulator (Model: RJNS6-1) | Mar 18, 2022 | Substantially Equivalent | Bozhou Rongjian Medical Appliance Co., Ltd. |
| K202861 | Needle Stimulator | Aug 27, 2021 | Substantially Equivalent | Wuxi Jiajian Medical Instrument Co., Ltd. |
| K200636 | AXUS ES-5 Electro-Acupuncture Device | Feb 03, 2021 | Substantially Equivalent | Lhasa Oms, Inc. |
| K170391 | ANSiStim-PP | Mar 09, 2017 | Substantially Equivalent | Dyansys, Inc. |
| K152571 | Stivax | May 26, 2016 | Substantially Equivalent | Biegler GmbH |
| K141168 | ANSISTIM | May 15, 2015 | Substantially Equivalent | Dyansys, Inc. |
| K133980 | PANTHEON ELECTROSTIMULATOR | Nov 07, 2014 | Substantially Equivalent | Pantheon Research |
| K140530 | Electro Auricular Device | Oct 02, 2014 | Substantially Equivalent | Navigant Consulting, Inc. |
| K140788 | P-STIM | Jun 27, 2014 | Substantially Equivalent | Biegler GmbH |
| K130768 | JIAJIAN CMN STIMULATOR | Aug 16, 2013 | Substantially Equivalent | Wuxi Jiajian Medical Instrument Co., Ltd. |
| K122812 | JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS | Apr 11, 2013 | Substantially Equivalent | Wuxi Jiajian Medical Instrument Co., Ltd. |
| K093322 | MULTI-PURPOSE HEALTH DEVICE | Aug 05, 2010 | Substantially Equivalent | Upc Medical Supplies, Inc. Dba United Pacific Co. |
| K091933 | ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01 | Apr 02, 2010 | Substantially Equivalent | Inno-Health Technology, Inc. |
| K091875 | E-PULSE | Dec 07, 2009 | Substantially Equivalent | Medevice Corporation |
| K081943 | MODEL ES-130 | Nov 24, 2008 | Substantially Equivalent | Ito Co., Ltd. |
| K050123 | P-STIM SYSTEM | Mar 30, 2006 | Substantially Equivalent | Neuroscience Therapy Corp. |
| K051197 | ACULIFE, MODEL SMW-01 | Mar 28, 2006 | Substantially Equivalent | Inno-Health Technology, Inc. |
| K014273 | ACUSTIM | Jun 12, 2002 | Substantially Equivalent | S.H.P. Intl. Pty., Ltd. |
| K840995 | ACUPUNCTURE INSOLES | Mar 27, 1984 | Substantially Equivalent | Lu LU Enterprise Co. , Ltd. |
| K840983 | PULSELIFE STIMULATOR | Mar 27, 1984 | Substantially Equivalent | Pulse Life, Inc. |
| K832634 | SELECTRODE SYSTEM | Jan 25, 1984 | Substantially Equivalent | Bio-Stimu Trend Corp. |
| K781651 | HEALTH POINT | Apr 03, 1979 | Substantially Equivalent | Anritsu America Co. |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.