Cleared Traditional

K190988 - GIM-STIM OTC TENS/EMS System

K190988 is the FDA 510(k) clearance for GIM-STIM OTC TENS/EMS System by Gemore Technology Co, Ltd.. It is a Class 2 Neurology device (product code NUH) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K190988 · Gemore Technology Co, Ltd. · Neurology device
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Aug 2019
Decision
123d
Days
Class 2
Risk

K190988 is an FDA 510(k) clearance for the GIM-STIM OTC TENS/EMS System. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Gemore Technology Co, Ltd. (Tan Shui, New Taipei City, TW). The FDA issued a Cleared decision on August 16, 2019 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gemore Technology Co, Ltd. devices

Submission Details

510(k) Number K190988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 148d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NUH Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Temporary Relief Of Pain Due To Sore/aching Muscles
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - NUH Stimulator, Nerve, Transcutaneous, Over-the-counter

All 140
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K190988.
Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)
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K191151 · Jkh USA, LLC · Jun 2019