Thera Pulse a Electro Nerve Stimulator
FDA 510(k) K925686 · Biomedical Life Systems, Inc.
510(k) numberK925686
Submission
- Device name
- Thera Pulse a Electro Nerve Stimulator
- Applicant
- Biomedical Life Systems, Inc.
Vista, CA, US - Received
- November 12, 1992
- Decision date
- March 18, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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|---|---|---|---|
| K252712 | STIMPOD NMS460 Nerve StimulatorGZJ · Traditional | Algiamed Technologies USA, Inc. | 05/28/2026SE |
| K252767 | actiTENS miniGZJ · Traditional | Sublimed | 01/16/2026SE |
| K252236 | CP Relief Wand Rx - TENS/NMESGZJ · Special | N & C Holdings, LLC | 08/15/2025SE |
| K232441 | Unipro (K-UNIPRO-US)GZJ · Traditional | Tenscare, Ltd. | 08/30/2024SE |
| K241228 | TENSWaveGZJ · Abbreviated | Zynex Medical Officer | 08/27/2024SE |
| K233046 | Electrical Neuromuscular Stimulator, Cure TrioGZJ · Traditional | Oriental Inspiration Limited | 04/19/2024SE |
| K222879 | Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)GZJ · Traditional | Wuxi Jiajian Medical Instrument Co., Ltd. | 01/24/2023SE |
| K212618 | iRelieve Microcurrent Pain Relief SystemGZJ · Traditional | Fast Track Technologies, Inc. | 09/14/2022SE |
| K213802 | StimOnTM Pain Relief System (GM2439)GZJ · Traditional | Gimer Medical Co., Ltd. | 08/26/2022SE |
| K220578 | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)GZJ · Traditional | Bozhou Rongjian Medical Appliance Co., Ltd. | 05/25/2022SE |
More from Bozhou Rongjian Medical Appliance Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K172971 | BMLS16-1NUH · Traditional | 07/08/2018SE |
| K102051 | Pain BuddyNUH · Traditional | 07/29/2011SE |
| K061476 | Electro-Nerve Stimulator TENS, Model BMLS06-1GZJ · Traditional | 07/26/2006SE |
| K042711 | Model BMLS03-7GZJ · Traditional | 03/14/2005SE |
| K041388 | Combination Powered Electrical Muscle Stimulator and Interferential Stimulator, Model…GZJ · Traditional | 11/23/2004SE |
| K040007 | Interferential Stimulator, Model BMLS02-6LIH · Traditional | 07/07/2004SE |
| K033174 | BMLS03-3IPF · Traditional | 06/30/2004SE |
| K040824 | Interferential Stimulator, Model BMLS03-6LIH · Traditional | 04/29/2004SE |
| K040306 | High Voltage Pulsed Stimulator, Model BMLS02-7IPF · Traditional | 03/23/2004SE |
| K033455 | Electro-Nerve Stimulator TENS, Model BMLS03-5GZJ · Traditional | 01/15/2004SE |
Questions and answers
When was Thera Pulse a Electro Nerve Stimulator cleared by the FDA?
Thera Pulse a Electro Nerve Stimulator (K925686) received a 510(k) decision of Substantially Equivalent on March 18, 1993, 126 days after the submission was received.
What is the product code of K925686?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.