Cleared Traditional

K150043 - Transcutaneous Electrical Nerve Stimula...

K150043 is the FDA 510(k) clearance for Transcutaneous Electrical Nerve Stimula... by Andon Health Co, Ltd.. It is a Class 2 Neurology device (product code NUH) cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K150043 · Andon Health Co, Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
217d
Days
Class 2
Risk

K150043 is an FDA 510(k) clearance for the Transcutaneous Electrical Nerve Stimulators (TENS). Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on August 14, 2015 after a review of 217 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.

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Submission Details

510(k) Number K150043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2015
Decision Date August 14, 2015
Days to Decision 217 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
69d slower than avg
Panel avg: 148d · This submission: 217d
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 134
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K150043.
Balego TENS Digital Edition with Accessories for Pain Relief (OTC)
K181207 · Everyway Medical Instruments Co., Ldt. · Jun 2018
EV-804 OTC Pain Relief TENS
K172919 · Everyway Medical Instruments Co.,Ltd · Apr 2018
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
K171802 · Bayer Healthcare, LLC · Mar 2018