Cleared Traditional

K941412 - WAHL COMPACT COMFORT MASSAGER

K941412 is an FDA 510(k) clearance for WAHL COMPACT COMFORT MASSAGER, manufactured by Wahl Clipper Corp.. The device is a Class 1 Physical Medicine device with product code IRO cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K941412 · Wahl Clipper Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K941412

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.

IRO Device Classification - Class 1, General Controls

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 22
Devices cleared under the same product code (IRO) and FDA review panel - the closest regulatory comparables to K941412.
CONAIR FAMILY FITNESS BODY ENERGY
K950441 · Conair Corp. · Jul 1995
CONAIR BODY AND SOLE
K950410 · Conair Corp. · May 1995
SQUEEZE PLAY
K943730 · Conair Corp. · Nov 1994
SONASSAGE
K923238 · Conair Corp. · Feb 1994
CARAPACE SUTURE REMOVAL TRAYS
K931819 · Carapace, Inc. · Jan 1994
HEALTLH ESSENTIALS PERSONAL MASSAGER
K924431 · Conair Corp. · Oct 1993