Cleared Traditional

WITOUCH PRO

K120398 · Hollywog, LLC · Neurology
Aug 2012
Decision
190d
Days
Class 2
Risk

About This 510(k) Submission

K120398 is an FDA 510(k) clearance for the WITOUCH PRO, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Hollywog, LLC (Chattanooga, US). The FDA issued a Cleared decision on August 16, 2012, 190 days after receiving the submission on February 8, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K120398 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2012
Decision Date August 16, 2012
Days to Decision 190 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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