Cleared Traditional

K151479 - EV-820 OTC Pain Relief TENS

K151479 is the FDA 510(k) clearance for EV-820 OTC Pain Relief TENS by Everyway Medical Instruments Co.,Ltd. It is a Class 2 Neurology device (product code NUH) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K151479 · Everyway Medical Instruments Co.,Ltd · Neurology device
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Oct 2015
Decision
136d
Days
Class 2
Risk

K151479 is an FDA 510(k) clearance for the EV-820 OTC Pain Relief TENS. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Everyway Medical Instruments Co.,Ltd (Shenkeng Hsiang, Taipei Hsien, TW). The FDA issued a Cleared decision on October 16, 2015 after a review of 136 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 Everyway Medical Instruments Co.,Ltd devices

Submission Details

510(k) Number K151479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2015
Decision Date October 16, 2015
Days to Decision 136 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
12d faster than avg
Panel avg: 148d · This submission: 136d
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 K151479.
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