Tenscare, Model TENS XL-2
FDA 510(k) K003591 · Tenscare, Ltd.
510(k) numberK003591
Submission
- Device name
- Tenscare, Model TENS XL-2
- Applicant
- Tenscare, Ltd.
Timperley, Cheshire, GB - Received
- November 21, 2000
- Decision date
- February 14, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K232441 | Unipro (K-UNIPRO-US)GZJ · Traditional | 08/30/2024SE |
| K230926 | Ova+ (K-OVAP-USA)NUH · Traditional | 12/15/2023SE |
| K230983 | Unicare (K-UNICARE-USA)KPI · Traditional | 10/20/2023SE |
| K231053 | Unicare (K-UNICARE-USA)NUH · Traditional | 08/18/2023SE |
| K200694 | Perfect EMSNUH · Traditional | 06/04/2021SE |
| K191312 | Perfect PFEKPI · Traditional | 11/01/2019SE |
| K142506 | TensCare KegelFitKPI · Traditional | 04/20/2015SE |
| K103698 | Tenscare Itouch Sure Model ItsKPI · Traditional | 06/21/2011SE |
| K082377 | Tenscare Itouch Model(S) Easy and PlusGZJ · Abbreviated | 02/09/2009SE |
| K023997 | Tenscare Ultima Nms/EmsIPF · Traditional | 03/03/2003SE |
Questions and answers
When was Tenscare, Model TENS XL-2 cleared by the FDA?
Tenscare, Model TENS XL-2 (K003591) received a 510(k) decision of Substantially Equivalent on February 14, 2001, 85 days after the submission was received.
What is the product code of K003591?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.