Cleared Special

K063660 - OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407

K063660 is an FDA 510(k) clearance for OTC TENS FOR LOW BACK PAIN RELIEF, 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 61-day FDA review.

K063660 · 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 2007
Decision
61d
Days
Class 2
Risk

K063660 is an FDA 510(k) clearance for the OTC TENS FOR LOW BACK 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 (Kowloon, HK). The FDA issued a Cleared decision on February 7, 2007 after a review of 61 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.

FDA 510(k) Submission Details - K063660

510(k) Number K063660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2006
Decision Date February 07, 2007
Days to Decision 61 days
Submission Type Special
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
88d faster than avg
Panel avg: 149d · This submission: 61d
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 229
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K063660.
THERAPEUTIC MASSAGE COMPANION
K060846 · Endurance Therapeutics · Dec 2007
RHYTHM TOUCH Q 2-WAY
K063743 · Shockim Enterprises, Ltd. · May 2007
ELECTROPULSE - LOW BACK PAIN
K062532 · Pain Relief Technologies · Feb 2007
LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP
K060222 · Gemore Technology Co, Ltd. · Apr 2006
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406
K052785 · Well-Life Healthcare Limited · Mar 2006
5000Z SYSTEM (OTC)
K033122 · Prizm Medical, Inc. · Aug 2004
K063660 · OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407
Download PDF FDA Summary Well-Life Healthcare …