Unicare (K-UNICARE-USA)

FDA 510(k) K231053 · Tenscare, Ltd.

Substantially Equivalent

510(k) numberK231053

Submission

Device name
Unicare (K-UNICARE-USA)
Applicant
Tenscare, Ltd.
Epsom, GB
Received
April 13, 2023
Decision date
August 18, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

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K253896TENS/EMS device (GUSE01)NUH · Traditional Globalcare Medical Technology Co., Ltd.03/04/2026SE
K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)NUH · Traditional Shenzhen Jiantuo Electronics Co., Ltd.12/31/2025SE
K253740Tens&Ems (HZ9151B, HZ9151C, HZ9151D)NUH · Traditional Hong Qiangxing (Shenzhen) Electronics Limited12/23/2025SE
K251958VEINOPLUS BackNUH · Traditional Dynapulse Medical12/23/2025SE
K252688Transcutaneous Electrical Nerve Stimulator (RJTENS-2)NUH · Traditional Bozhou Rongjian Medical Appliance Co., Ltd.11/24/2025SE
K251856Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4NUH · Special Everyway Medical Instruments Co.,Ltd11/21/2025SE
K243131Triathlon ProNUH · Traditional Sigma Biomedical11/07/2025SE

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K230926Ova+ (K-OVAP-USA)NUH · Traditional 12/15/2023SE
K230983Unicare (K-UNICARE-USA)KPI · Traditional 10/20/2023SE
K200694Perfect EMSNUH · Traditional 06/04/2021SE
K191312Perfect PFEKPI · Traditional 11/01/2019SE
K142506TensCare KegelFitKPI · Traditional 04/20/2015SE
K103698Tenscare Itouch Sure Model ItsKPI · Traditional 06/21/2011SE
K082377Tenscare Itouch Model(S) Easy and PlusGZJ · Abbreviated 02/09/2009SE
K023997Tenscare Ultima Nms/EmsIPF · Traditional 03/03/2003SE
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Questions and answers

When was Unicare (K-UNICARE-USA) cleared by the FDA?

Unicare (K-UNICARE-USA) (K231053) received a 510(k) decision of Substantially Equivalent on August 18, 2023, 127 days after the submission was received.

What is the product code of K231053?

The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.