Cleared Abbreviated

GEMORE TENS SYSTEM

K120569 · Gemore Technology Co, Ltd. · Neurology
Jul 2012
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K120569 is an FDA 510(k) clearance for the GEMORE TENS SYSTEM, 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 July 20, 2012, 144 days after receiving the submission on February 27, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K120569 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2012
Decision Date July 20, 2012
Days to Decision 144 days
Submission Type Abbreviated
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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