Cleared Traditional

Unipro (K-UNIPRO-US)

K232441 · Tenscare, Ltd. · Neurology
Aug 2024
Decision
382d
Days
Class 2
Risk

About This 510(k) Submission

K232441 is an FDA 510(k) clearance for the Unipro (K-UNIPRO-US), a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Tenscare, Ltd. (Epsom, GB). The FDA issued a Cleared decision on August 30, 2024, 382 days after receiving the submission on August 14, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K232441 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2023
Decision Date August 30, 2024
Days to Decision 382 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GZJ — Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5890

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