Cleared Traditional

K933974 - WINDMERE MASSAGE MATE

K933974 is an FDA 510(k) clearance for WINDMERE MASSAGE MATE, manufactured by Windmere Corp.. The device is a Class 1 Physical Medicine device with product code IRO cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K933974 · Windmere Corp. · Physical Medicine device
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Feb 1994
Decision
173d
Days
Class 1
Risk

K933974 is an FDA 510(k) clearance for the WINDMERE MASSAGE MATE. Classified as Vibrator, Therapeutic (product code IRO), Class I - General Controls.

Submitted by Windmere Corp. (Miami Lakes, US). The FDA issued a Cleared decision on February 2, 1994 after a review of 173 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Windmere Corp. devices

FDA 510(k) Submission Details - K933974

510(k) Number K933974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1993
Decision Date February 02, 1994
Days to Decision 173 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
58d slower than avg
Panel avg: 115d · This submission: 173d
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 20
Devices cleared under the same product code (IRO) and FDA review panel - the closest regulatory comparables to K933974.
CONAIR BODY AND SOLE
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SONASSAGE
K923238 · Conair Corp. · Feb 1994
CARAPACE SUTURE REMOVAL TRAYS
K931819 · Carapace, Inc. · Jan 1994
HEALTLH ESSENTIALS PERSONAL MASSAGER
K924431 · Conair Corp. · Oct 1993
BODYTHERM
K924519 · Conair Corp. · Oct 1993