Cleared Abbreviated

K143430 - SmartTENS

K143430 is an FDA 510(k) clearance for SmartTENS, manufactured by Easy Med Instrument Co., Ltd.. The device is a Class 2 Neurology device with product code NUH cleared through the Abbreviated 510(k) pathway after a 179-day FDA review.

K143430 · Easy Med Instrument Co., Ltd. · Neurology device
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May 2015
Decision
179d
Days
Class 2
Risk

K143430 is an FDA 510(k) clearance for the SmartTENS. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Easy Med Instrument Co., Ltd. (Daliang, Shunde, Foshan, Guang Dong, CN). The FDA issued a Cleared decision on May 29, 2015 after a review of 179 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Easy Med Instrument Co., Ltd. devices

FDA 510(k) Submission Details - K143430

510(k) Number K143430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2014
Decision Date May 29, 2015
Days to Decision 179 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 148d · This submission: 179d
Pathway characteristics
Standards-based clearance path.

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 158
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K143430.
ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)
K152852 · Bayer Healthcare, LLC · Dec 2015
EV-820 OTC Pain Relief TENS
K151479 · Everyway Medical Instruments Co.,Ltd · Oct 2015
Transcutaneous Electrical Nerve Stimulators (TENS)
K150043 · Andon Health Co, Ltd. · Aug 2015
MAXPOWER RELIEF
K141978 · Omron Healthcare, Inc. · Dec 2014
OTC COMBO TENS/EMS SYSTEM
K141299 · Well-Life Healthcare Limited · Nov 2014
OTC PATCH
K133723 · Well-Life Healthcare Limited · Jan 2014