Cleared Traditional

K190988 - GIM-STIM OTC TENS/EMS System

K190988 is an FDA 510(k) clearance for GIM-STIM OTC TENS/EMS System, manufactured by Gemore Technology Co, Ltd.. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K190988

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.

NUH Device Classification - Class 2, Special Controls

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 219
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