Cleared Traditional

WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER (K950701) - FDA 510(k) Clearance

Class I Physical Medicine device.

K950701 · Wahl Clipper Corp. · Physical Medicine device
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Mar 1995
Decision
37d
Days
Class 1
Risk

K950701 is an FDA 510(k) clearance for the WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER. Classified as Pack, Heat, Moist (product code IMA), Class I - General Controls.

Submitted by Wahl Clipper Corp. (Steriling, US). The FDA issued a Cleared decision on March 24, 1995 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5730 - the FDA physical medicine 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wahl Clipper Corp. devices

Submission Details

510(k) Number K950701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1995
Decision Date March 24, 1995
Days to Decision 37 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 115d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IMA Pack, Heat, Moist
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5730
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.