Cleared Special

GEM-TWIN TENS/ MODELS GM3XY/Z

K042559 · Gemore Technology Co, Ltd. · Neurology
Nov 2004
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K042559 is an FDA 510(k) clearance for the GEM-TWIN TENS/ MODELS GM3XY/Z, 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 November 17, 2004, 57 days after receiving the submission on September 21, 2004. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K042559 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2004
Decision Date November 17, 2004
Days to Decision 57 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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