Cleared Traditional

K150681 - GEMORE OTC TENS
(FDA 510(k) Clearance)

K150681 · Gemore Technology Co, Ltd. · Neurology

May 2015

Decision

56d

Days

Class 2

Risk

K150681 is an FDA 510(k) clearance for the GEMORE OTC TENS, a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Gemore Technology Co, Ltd. (Tan Shui, New Taipei City, TW). The FDA issued a Cleared decision on May 12, 2015, 56 days after receiving the submission on March 17, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K150681 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 17, 2015
Decision Date	May 12, 2015
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	NUH — Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5890
Definition	Temporary Relief Of Pain Due To Sore/aching Muscles