Cleared Traditional

K150386 - Tyece OTC TENS Device (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K150386 · Tyece , Ltd. · Neurology device
Nov 2015
Decision
260d
Days
Class 2
Risk

K150386 is an FDA 510(k) clearance for the Tyece OTC TENS Device. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Tyece , Ltd. (Kowloon, HK). The FDA issued a Cleared decision on November 5, 2015 after a review of 260 days - an extended review 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: 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.

Submission Details

510(k) Number K150386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2015
Decision Date November 05, 2015
Days to Decision 260 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 162d · This submission: 260d
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 20
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K150386.
TENS/EMS device (GUSE01)
K253896 · Globalcare Medical Technology Co., Ltd. · Mar 2026
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Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
K252688 · Bozhou Rongjian Medical Appliance Co., Ltd. · Nov 2025
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K251856 · Everyway Medical Instruments Co.,Ltd · Nov 2025