Cleared Traditional

K151479 - EV-820 OTC Pain Relief TENS

K151479 is an FDA 510(k) clearance for EV-820 OTC Pain Relief TENS, manufactured by Everyway Medical Instruments Co.,Ltd. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K151479

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
Combination Product No
PCCP Authorized No
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.

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 K151479.
PainKARE
K151034 · Triowave Technologies · Nov 2015
Tyece OTC TENS Device
K150386 · Tyece , Ltd. · Nov 2015
Palm TENS
K150308 · Heat IN A Click, LLC · Oct 2015
Transcutaneous Electrical Nerve Stimulators (TENS)
K150043 · Andon Health Co, Ltd. · Aug 2015
TENS AND POWERED MUSCLE STIMULATOR
K143268 · Shenzhen As-Tec Technology Co., Ltd. · Jul 2015
PulseRelief
K151035 · Philips Consumer Lifestyle · Jul 2015