Cleared Traditional

K150681 - GEMORE OTC TENS

K150681 is the FDA 510(k) clearance for GEMORE OTC TENS by Gemore Technology Co, Ltd.. It is a Class 2 Neurology device (product code NUH) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K150681 · Gemore Technology Co, Ltd. · Neurology device
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May 2015
Decision
56d
Days
Class 2
Risk

K150681 is an FDA 510(k) clearance for the GEMORE OTC TENS. 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 May 12, 2015 after a review of 56 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gemore Technology Co, Ltd. devices

Submission Details

510(k) Number K150681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 148d · This submission: 56d
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 141
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K150681.
Heat Pain Pro
K160115 · Omron Healthcare, Inc. · Jun 2016
ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)
K152852 · Bayer Healthcare, LLC · Dec 2015
Transcutaneous Electrical Nerve Stimulators (TENS)
K150043 · Andon Health Co, Ltd. · Aug 2015
MAXPOWER RELIEF
K141978 · Omron Healthcare, Inc. · Dec 2014
MODEL PM3030
K110068 · Omron Healthcare, Inc. · Dec 2011
PAIN BUDDY
K102051 · Biomedical Life Systems, Inc. · Jul 2011