Classic TENS
FDA 510(k) K020437 · Care Rehab, Inc.
510(k) numberK020437
Submission
- Device name
- Classic TENS
- Applicant
- Care Rehab, Inc.
Mclean, VA, US - Received
- February 8, 2002
- Decision date
- March 15, 2002
- 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.
Questions and answers
When was Classic TENS cleared by the FDA?
Classic TENS (K020437) received a 510(k) decision of Substantially Equivalent on March 15, 2002, 35 days after the submission was received.
What is the product code of K020437?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.