Cleared Traditional

Unicare (K-UNICARE-USA)

K231053 · Tenscare, Ltd. · Neurology

Aug 2023

Decision

127d

Days

Class 2

Risk

About This 510(k) Submission

K231053 is an FDA 510(k) clearance for the Unicare (K-UNICARE-USA), a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Tenscare, Ltd. (Epsom, GB). The FDA issued a Cleared decision on August 18, 2023, 127 days after receiving the submission on April 13, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K231053 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 13, 2023
Decision Date	August 18, 2023
Days to Decision	127 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	NUH — Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5890
Definition	Temporary Relief Of Pain Due To Sore/aching Muscles