Cleared Traditional

WINDMERE MASSAGE MATE (K933974) - FDA 510(k) Clearance

Class I Physical Medicine device.

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

Submission Details

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.

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 K933974.
VARIABLE SPEED VIBRATOR, 120V 83-117 VIB
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VIBRATOR
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K800018 · Fred Sammons, Inc. · Jan 1980
HEAD FACILITATION VIBRATOR BK-5210
K771279 · Fred Sammons, Inc. · Aug 1977
ELECTRIC VIBRATOR
K761121 · Fred Sammons, Inc. · Dec 1976