Cleared Traditional

WINNER CM4 COMBINATION UNIT

K012848 · Rich-Mar Corp. · Neurology
Oct 2001
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K012848 is an FDA 510(k) clearance for the WINNER CM4 COMBINATION UNIT, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Rich-Mar Corp. (Inola, US). The FDA issued a Cleared decision on October 25, 2001, 63 days after receiving the submission on August 23, 2001. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K012848 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2001
Decision Date October 25, 2001
Days to Decision 63 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

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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