Cleared Special

K172809 - OTC Combo TENS/EMS System

K172809 is an FDA 510(k) clearance for OTC Combo TENS/EMS System, manufactured by Well-Life Healthcare Limited. The device is a Class 2 Neurology device with product code NUH cleared through the Special 510(k) pathway after a 30-day FDA review.

K172809 · Well-Life Healthcare Limited · Neurology device
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Oct 2017
Decision
30d
Days
Class 2
Risk

K172809 is an FDA 510(k) clearance for the OTC Combo TENS/EMS System. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Well-Life Healthcare Limited (Yunghe Dist, New Taipei City, TW). The FDA issued a Cleared decision on October 18, 2017 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Well-Life Healthcare Limited devices

FDA 510(k) Submission Details - K172809

510(k) Number K172809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2017
Decision Date October 18, 2017
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 219
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K172809.
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