Cleared Traditional

K091757 - OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407

K091757 is an FDA 510(k) clearance for OTC TENS FOR ARM AND LEG PAIN RELIEF, manufactured by Well-Life Healthcare Limited. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K091757 · Well-Life Healthcare Limited · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
234d
Days
Class 2
Risk

K091757 is an FDA 510(k) clearance for the OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Well-Life Healthcare Limited (Yunghe City, Taipei County, TW). The FDA issued a Cleared decision on February 5, 2010 after a review of 234 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 - K091757

510(k) Number K091757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2009
Decision Date February 05, 2010
Days to Decision 234 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
85d slower than avg
Panel avg: 149d · This submission: 234d
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
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K091757 · OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407
Download PDF FDA Summary Well-Life Healthcare …