Cleared Traditional

GIM-STIM OTC TENS/EMS System

K190988 · Gemore Technology Co, Ltd. · Neurology

Aug 2019

Decision

123d

Days

Class 2

Risk

About This 510(k) Submission

K190988 is an FDA 510(k) clearance for the GIM-STIM OTC TENS/EMS System, 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 August 16, 2019, 123 days after receiving the submission on April 15, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K190988 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 15, 2019
Decision Date	August 16, 2019
Days to Decision	123 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Statement

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