Cleared Traditional

K140650 - HIVOX ELECTRIC STIMULATOR OTC TENS

K140650 is an FDA 510(k) clearance for HIVOX ELECTRIC STIMULATOR OTC TENS, manufactured by Hivox Biotek, Inc.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K140650 · Hivox Biotek, Inc. · Neurology device
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Jun 2014
Decision
106d
Days
Class 2
Risk

K140650 is an FDA 510(k) clearance for the HIVOX ELECTRIC STIMULATOR OTC TENS. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Hivox Biotek, Inc. (Taipei Hsien, TW). The FDA issued a Cleared decision on June 27, 2014 after a review of 106 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 Hivox Biotek, Inc. devices

FDA 510(k) Submission Details - K140650

510(k) Number K140650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2014
Decision Date June 27, 2014
Days to Decision 106 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
43d faster than avg
Panel avg: 149d · This submission: 106d
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 228
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K140650.
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COUNTER OTC TENS DEVICE
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