Cleared Special

GEM-STIM COMBO STIMULATOR

K122948 · Gemore Technology Co, Ltd. · Neurology
Dec 2012
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K122948 is an FDA 510(k) clearance for the GEM-STIM COMBO STIMULATOR, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Gemore Technology Co, Ltd. (Tan Shui, New Taipei City, TW). The FDA issued a Cleared decision on December 21, 2012, 88 days after receiving the submission on September 24, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K122948 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2012
Decision Date December 21, 2012
Days to Decision 88 days
Submission Type Special
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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