Cleared Traditional

K931086 - WINDMERE VIBRA TOUCH PERSONAL BODY MASSAGER

K931086 is an FDA 510(k) clearance for WINDMERE VIBRA TOUCH PERSONAL BODY MASSAGER, 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 211-day FDA review.

K931086 · Windmere Corp. · Physical Medicine device
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Sep 1993
Decision
211d
Days
Class 1
Risk

K931086 is an FDA 510(k) clearance for the WINDMERE VIBRA TOUCH PERSONAL BODY MASSAGER. 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 September 30, 1993 after a review of 211 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 - K931086

510(k) Number K931086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1993
Decision Date September 30, 1993
Days to Decision 211 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
96d slower than avg
Panel avg: 115d · This submission: 211d
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 K931086.
HEALTH ESSENTIALS BODY CARE MASSAGER
K924582 · Conair Corp. · Oct 1993
HEALTH ESSENTIALS MULTI-PURPOSE MASSAGER
K924583 · Conair Corp. · Oct 1993
HEALTH ESSENTIALS FANCY PERSONAL MASSAGER
K924584 · Conair Corp. · Oct 1993
PAM PLUS
K913998 · Kinetic Concepts, Inc. · Jan 1992
TOUCH N TONE 1 MASSAGER
K915242 · Conair Corp. · Dec 1991
MULTI-REACH II WAND MASSAGER
K914344 · Conair Corp. · Oct 1991