Cleared Traditional

GEM-STIM TENS, MODELS GM3XY AND GM3AXY

K032720 · Gemore Technology Co, Ltd. · Neurology
Dec 2003
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K032720 is an FDA 510(k) clearance for the GEM-STIM TENS, MODELS GM3XY AND GM3AXY, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Gemore Technology Co, Ltd. (Tan Shui, Taipei Hsien, TW). The FDA issued a Cleared decision on December 10, 2003, 99 days after receiving the submission on September 2, 2003. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K032720 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 2003
Decision Date December 10, 2003
Days to Decision 99 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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