Cleared Traditional

K171599 - WiTouch Pro, WiTouch, Neubac

K171599 is an FDA 510(k) clearance for WiTouch Pro, manufactured by Hollywog, LLC. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K171599 · Hollywog, LLC · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
113d
Days
Class 2
Risk

K171599 is an FDA 510(k) clearance for the WiTouch Pro, WiTouch, Neubac. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Hollywog, LLC (Chattanooga, US). The FDA issued a Cleared decision on September 22, 2017 after a review of 113 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.

FDA 510(k) Submission Details - K171599

510(k) Number K171599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2017
Decision Date September 22, 2017
Days to Decision 113 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
36d faster than avg
Panel avg: 149d · This submission: 113d
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 K171599.
Mytens Model: BW-TSX
K171026 · Bewell Connect Corp. · Nov 2017
Avail
K172079 · Omron Healthcare, Inc. · Oct 2017
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Pain Therapy Device
K163611 · Guangzhou Xinbo Electronic Co., Ltd. · Sep 2017
EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only
K163166 · Easywell Biomedicals, Inc. · Aug 2017
Hi-Dow Wireless TENS/EMS System (Model HD-5N)
K163393 · Hi-Dow International, Inc. · Aug 2017