Cleared Traditional

K060846 - THERAPEUTIC MASSAGE COMPANION

K060846 is an FDA 510(k) clearance for THERAPEUTIC MASSAGE COMPANION, manufactured by Endurance Therapeutics. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 615-day FDA review.

K060846 · Endurance Therapeutics · Neurology device
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Dec 2007
Decision
615d
Days
Class 2
Risk

K060846 is an FDA 510(k) clearance for the THERAPEUTIC MASSAGE COMPANION. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Endurance Therapeutics (Dauphin, Manitoba, CA). The FDA issued a Cleared decision on December 3, 2007 after a review of 615 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Endurance Therapeutics devices

FDA 510(k) Submission Details - K060846

510(k) Number K060846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2006
Decision Date December 03, 2007
Days to Decision 615 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
467d slower than avg
Panel avg: 148d · This submission: 615d
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 164
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K060846.
CARE BACK PAIN RELIEF STIMULATOR
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K091757 · Well-Life Healthcare Limited · Feb 2010
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407
K063660 · Well-Life Healthcare Limited · Feb 2007
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406
K052785 · Well-Life Healthcare Limited · Mar 2006