Unipro (K-UNIPRO-US)
FDA 510(k) K232441 · Tenscare, Ltd.
510(k) numberK232441
Submission
- Device name
- Unipro (K-UNIPRO-US)
- Applicant
- Tenscare, Ltd.
Epsom, GB - Received
- August 14, 2023
- Decision date
- August 30, 2024
- 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 |
| 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 |
| K220503 | TENS device-EmeTerm 2, Model: YF-ZTY-E2GZJ · Traditional | Wat Medical Technology, Inc. | 04/23/2022SE |
More from Wat Medical Technology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K020846 | Ultima TENS XL-A1GZJ · Traditional | 05/21/2002SE |
Questions and answers
When was Unipro (K-UNIPRO-US) cleared by the FDA?
Unipro (K-UNIPRO-US) (K232441) received a 510(k) decision of Substantially Equivalent on August 30, 2024, 382 days after the submission was received.
What is the product code of K232441?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.