Cleared Traditional

K163166 - EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only

K163166 is an FDA 510(k) clearance for EASYWELL TENS System TENS and Heat, manufactured by Easywell Biomedicals, Inc.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K163166 · Easywell Biomedicals, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
270d
Days
Class 2
Risk

K163166 is an FDA 510(k) clearance for the EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Easywell Biomedicals, Inc. (Hsinchu, TW). The FDA issued a Cleared decision on August 11, 2017 after a review of 270 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.

FDA 510(k) Submission Details - K163166

510(k) Number K163166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2016
Decision Date August 11, 2017
Days to Decision 270 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
121d slower than avg
Panel avg: 149d · This submission: 270d
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 229
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K163166.
OTC Combo TENS/EMS System
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K171599 · Hollywog, LLC · Sep 2017
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Hi-Dow Wireless TENS/EMS System (Model HD-5N)
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Livia
K163153 · Lifecare , Ltd. · Jun 2017
IQ Technologies
K170659 · Iq Technologies, Inc. · May 2017