Cleared Traditional

K163393 - Hi-Dow Wireless TENS/EMS System (Model ...

K163393 is an FDA 510(k) clearance for Hi-Dow Wireless TENS/EMS System (Model ..., manufactured by Hi-Dow International, Inc.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K163393 · Hi-Dow International, Inc. · Neurology device
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Aug 2017
Decision
245d
Days
Class 2
Risk

K163393 is an FDA 510(k) clearance for the Hi-Dow Wireless TENS/EMS System (Model HD-5N). Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Hi-Dow International, Inc. (Maryland Heights, US). The FDA issued a Cleared decision on August 4, 2017 after a review of 245 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.

View all Hi-Dow International, Inc. devices

FDA 510(k) Submission Details - K163393

510(k) Number K163393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2016
Decision Date August 04, 2017
Days to Decision 245 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
97d slower than avg
Panel avg: 148d · This submission: 245d
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 150
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K163393.
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