Cleared Special

K052785 - OTC TENS FOR LOW BACK PAIN RELIEF

K052785 is the FDA 510(k) clearance for OTC TENS FOR LOW BACK PAIN RELIEF by Well-Life Healthcare Limited. It is a Class 2 Neurology device (product code NUH) cleared through the Special 510(k) pathway after a 165-day FDA review.

K052785 · Well-Life Healthcare Limited · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
165d
Days
Class 2
Risk

K052785 is an FDA 510(k) clearance for the OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Well-Life Healthcare Limited (Kowloon, HK). The FDA issued a Cleared decision on March 17, 2006 after a review of 165 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. 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. Standard predicate reliance. 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

Submission Details

510(k) Number K052785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2005
Decision Date March 17, 2006
Days to Decision 165 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 148d · This submission: 165d
Pathway characteristics
Modification to existing cleared device.

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.