Cleared Traditional

WAHL COMPACT COMFORT MASSAGER (K941412) - FDA 510(k) Clearance

Class I Physical Medicine device.

K941412 · Wahl Clipper Corp. · Physical Medicine device
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Jun 1994
Decision
78d
Days
Class 1
Risk

K941412 is an FDA 510(k) clearance for the WAHL COMPACT COMFORT MASSAGER. Classified as Vibrator, Therapeutic (product code IRO), 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 78 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5975 - 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 K941412 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 23, 1994
Decision Date June 09, 1994
Days to Decision 78 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
37d faster than avg
Panel avg: 115d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IRO Vibrator, Therapeutic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5975
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 - IRO Vibrator, Therapeutic

All 64
Devices cleared under the same product code (IRO) and FDA review panel - the closest regulatory comparables to K941412.
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ELECTRIC VIBRATOR
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