Cleared Traditional

K171599 - WiTouch Pro, WiTouch, Neubac (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171599 · Hollywog, LLC · Neurology device
Download Printable Device Report (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.

View all Hollywog, LLC devices

Submission Details

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
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 148d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 226
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K171599.
TENS/EMS device (GUSE01)
K253896 · Globalcare Medical Technology Co., Ltd. · Mar 2026
TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
K253305 · Shenzhen Jiantuo Electronics Co., Ltd. · Dec 2025
VEINOPLUS Back
K251958 · Dynapulse Medical · Dec 2025
TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
K253740 · Hong Qiangxing (Shenzhen) Electronics Limited · Dec 2025
Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
K252688 · Bozhou Rongjian Medical Appliance Co., Ltd. · Nov 2025
Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
K251856 · Everyway Medical Instruments Co.,Ltd · Nov 2025