# BWK · Stimulator, Electro-Acupuncture

_ ·  · Class U_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/NE-misc/BWK

## Overview

- **Product Code:** BWK
- **Device Name:** Stimulator, Electro-Acupuncture
- **Regulation:** 21 CFR N/A
- **Device Class:** U
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (20 of 23)

Showing 20 most recent of 23 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K244030](https://fda.innolitics.com/submissions/NE/NE-misc/BWK/K244030.md) | Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) | Wuxi Jiajian Medical Instrument Co., Ltd. | Mar 28, 2025 | SESE |
| [K220153](https://fda.innolitics.com/submissions/NE/NE-misc/BWK/K220153.md) | Needle Stimulator (Model: RJNS6-1) | Bozhou Rongjian Medical Appliance Co., Ltd. | Mar 18, 2022 | SESE |
| [K202861](https://fda.innolitics.com/submissions/NE/NE-misc/BWK/K202861.md) | Needle Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | Aug 27, 2021 | SESE |
| [K200636](https://fda.innolitics.com/submissions/NE/NE-misc/BWK/K200636.md) | AXUS ES-5 Electro-Acupuncture Device | Lhasa Oms, Inc. | Feb 3, 2021 | SESE |
| [K170391](https://fda.innolitics.com/submissions/NE/NE-misc/BWK/K170391.md) | ANSiStim-PP | Dyansys, Inc. | Mar 9, 2017 | SESE |
| [K152571](https://fda.innolitics.com/submissions/NE/NE-misc/BWK/K152571.md) | Stivax | Biegler GmbH | May 26, 2016 | SESE |
| [K141168](https://fda.innolitics.com/submissions/NE/NE-misc/BWK/K141168.md) | ANSISTIM | Dyansys, Inc. | May 15, 2015 | SESE |
| [K133980](https://fda.innolitics.com/submissions/NE/NE-misc/BWK/K133980.md) | PANTHEON ELECTROSTIMULATOR | Pantheon Research | Nov 7, 2014 | SESE |
| [K140530](https://fda.innolitics.com/submissions/NE/NE-misc/BWK/K140530.md) | Electro Auricular Device | Navigant Consulting, Inc. | Oct 2, 2014 | SESE |
| [K140788](https://fda.innolitics.com/submissions/NE/NE-misc/BWK/K140788.md) | P-STIM | Biegler GmbH | Jun 27, 2014 | SESE |
| [K130768](https://fda.innolitics.com/submissions/NE/NE-misc/BWK/K130768.md) | JIAJIAN CMN STIMULATOR | Wuxi Jiajian Medical Instrument Co., Ltd. | Aug 16, 2013 | SESE |
| [K122812](https://fda.innolitics.com/submissions/NE/NE-misc/BWK/K122812.md) | JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS | Wuxi Jiajian Medical Instrument Co., Ltd. | Apr 11, 2013 | SESE |
| [K093322](https://fda.innolitics.com/submissions/NE/NE-misc/BWK/K093322.md) | MULTI-PURPOSE HEALTH DEVICE | Upc Medical Supplies, Inc. Dba United Pacific Co. | Aug 5, 2010 | SESE |
| [K091933](https://fda.innolitics.com/submissions/NE/NE-misc/BWK/K091933.md) | ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01 | Inno-Health Technology, Inc. | Apr 2, 2010 | SESE |
| [K091875](https://fda.innolitics.com/submissions/NE/NE-misc/BWK/K091875.md) | E-PULSE | Medevice Corporation | Dec 7, 2009 | SESE |
| [K081943](https://fda.innolitics.com/submissions/NE/NE-misc/BWK/K081943.md) | MODEL ES-130 | Ito Co., Ltd. | Nov 24, 2008 | SESE |
| [K050123](https://fda.innolitics.com/submissions/NE/NE-misc/BWK/K050123.md) | P-STIM SYSTEM | Neuroscience Therapy Corp. | Mar 30, 2006 | SESE |
| [K051197](https://fda.innolitics.com/submissions/NE/NE-misc/BWK/K051197.md) | ACULIFE, MODEL SMW-01 | Inno-Health Technology, Inc. | Mar 28, 2006 | SESE |
| [K014273](https://fda.innolitics.com/submissions/NE/NE-misc/BWK/K014273.md) | ACUSTIM | S.H.P. Intl. Pty., Ltd. | Jun 12, 2002 | SESE |
| [K840995](https://fda.innolitics.com/submissions/NE/NE-misc/BWK/K840995.md) | ACUPUNCTURE INSOLES | Lu LU Enterprise Co. , Ltd. | Mar 27, 1984 | SESE |

## Top Applicants

- Wuxi Jiajian Medical Instrument Co., Ltd. — 4 clearances
- Biegler GmbH — 2 clearances
- Dyansys, Inc. — 2 clearances
- Inno-Health Technology, Inc. — 2 clearances
- Anritsu America Co. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/NE/NE-misc/BWK](https://fda.innolitics.com/submissions/NE/NE-misc/BWK)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com