Endura Reusable TENS and Nmes Electrodes
FDA 510(k) K946230 · Selectivemed Components, Inc.
510(k) numberK946230
Submission
- Device name
- Endura Reusable TENS and Nmes Electrodes
- Applicant
- Selectivemed Components, Inc.
Mt. Vernon, OH, US - Received
- December 22, 1994
- Decision date
- December 22, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GZJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K120922 | Guardian Dysphagia Dual Channel Nmes UnitIPF · Abbreviated | 02/07/2013SE |
| K083756 | Guardian 150 ElectrodeGXY · Traditional | 06/26/2009SE |
| K031053 | Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes…EGJ · Traditional | 05/20/2003SE |
| K020476 | Medion 6000EGJ · Traditional | 05/03/2002SE |
| K993081 | Io-DriveEGJ · Traditional | 03/03/2000SE |
| K945676 | Guardian Disposable TENS and Tens/Nmes ElectrodesGZJ · Traditional | 01/30/1995SE |
Questions and answers
When was Endura Reusable TENS and Nmes Electrodes cleared by the FDA?
Endura Reusable TENS and Nmes Electrodes (K946230) received a 510(k) decision of Substantially Equivalent on December 22, 1995, 365 days after the submission was received.
What is the product code of K946230?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.