Cleared Traditional

K150043 - Transcutaneous Electrical Nerve Stimulators (TENS)

K150043 is an FDA 510(k) clearance for Transcutaneous Electrical Nerve Stimula..., manufactured by Andon Health Co, Ltd.. The device is a Class 2 Neurology device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K150043

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
68d slower than avg
Panel avg: 149d · This submission: 217d
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 K150043.
Tyece OTC TENS Device
K150386 · Tyece , Ltd. · Nov 2015
Palm TENS
K150308 · Heat IN A Click, LLC · Oct 2015
EV-820 OTC Pain Relief TENS
K151479 · Everyway Medical Instruments Co.,Ltd · Oct 2015
TENS AND POWERED MUSCLE STIMULATOR
K143268 · Shenzhen As-Tec Technology Co., Ltd. · Jul 2015
PulseRelief
K151035 · Philips Consumer Lifestyle · Jul 2015
Electronic Pulse Stimulator
K150995 · Shenzhen Jingkehui Electronic Co.., Ltd. · Jul 2015
K150043 · Transcutaneous Electrical Nerve Stimulators (TENS)
Download PDF FDA Summary Andon Health Co, Ltd.