Cleared Traditional

K170145 - Digital TENS Unit

K170145 is an FDA 510(k) clearance for Digital TENS Unit, manufactured by Shenzhen Eapply Technology Co., Ltd.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K170145 · Shenzhen Eapply Technology Co., Ltd. · Neurology device
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Optimized for regulatory review, auditing and printing
Apr 2017
Decision
102d
Days
Class 2
Risk

K170145 is an FDA 510(k) clearance for the Digital TENS Unit. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Shenzhen Eapply Technology Co., Ltd. (Shenzhen City, CN). The FDA issued a Cleared decision on April 29, 2017 after a review of 102 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 Shenzhen Eapply Technology Co., Ltd. devices

FDA 510(k) Submission Details - K170145

510(k) Number K170145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2017
Decision Date April 29, 2017
Days to Decision 102 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
46d faster than avg
Panel avg: 148d · This submission: 102d
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 145
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K170145.
EV-804 OTC Pain Relief TENS
K172919 · Everyway Medical Instruments Co.,Ltd · Apr 2018
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
K171802 · Bayer Healthcare, LLC · Mar 2018
Avail
K172079 · Omron Healthcare, Inc. · Oct 2017
Electronic Pulse Stimulator
K160508 · Beijing Choice Electronic Technololgy Co., Ltd. · Nov 2016
Heat Pain Pro
K160115 · Omron Healthcare, Inc. · Jun 2016
ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)
K152852 · Bayer Healthcare, LLC · Dec 2015