Cleared Traditional

K941594 - WAHL DOUBLE COMFORT MASSAGER

K941594 is an FDA 510(k) clearance for WAHL DOUBLE COMFORT MASSAGER, manufactured by Wahl Clipper Corp.. The device is a Class 1 Physical Medicine device with product code ISA cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K941594 · Wahl Clipper Corp. · Physical Medicine device
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Jun 1994
Decision
69d
Days
Class 1
Risk

K941594 is an FDA 510(k) clearance for the WAHL DOUBLE COMFORT MASSAGER. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Wahl Clipper Corp. (Steriling, US). The FDA issued a Cleared decision on June 9, 1994 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5660 - 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

FDA 510(k) Submission Details - K941594

510(k) Number K941594 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 01, 1994
Decision Date June 09, 1994
Days to Decision 69 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

ISA Device Classification - Class 1, General Controls

Product Code ISA Massager, Therapeutic, Electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5660
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.

Regulatory Peers - ISA Massager, Therapeutic, Electric

All 28
Devices cleared under the same product code (ISA) and FDA review panel - the closest regulatory comparables to K941594.
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