Cleared Traditional

K915242 - TOUCH N TONE 1 MASSAGER

K915242 is the FDA 510(k) clearance for TOUCH N TONE 1 MASSAGER by Conair Corp.. It is a Class 1 Physical Medicine device (product code IRO) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K915242 · Conair Corp. · Physical Medicine device
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Dec 1991
Decision
37d
Days
Class 1
Risk

K915242 is an FDA 510(k) clearance for the TOUCH N TONE 1 MASSAGER. Classified as Vibrator, Therapeutic (product code IRO), Class I - General Controls.

Submitted by Conair Corp. (Stamford, US). The FDA issued a Cleared decision on December 20, 1991 after a review of 37 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 Conair Corp. devices

Submission Details

510(k) Number K915242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1991
Decision Date December 20, 1991
Days to Decision 37 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 115d · This submission: 37d
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 18
Devices cleared under the same product code (IRO) and FDA review panel - the closest regulatory comparables to K915242.
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
MULTI-REACH II WAND MASSAGER
K914344 · Conair Corp. · Oct 1991
VASOTRAIN 447
K871107 · Henley Intl. · May 1987
VARIABLE SPEED VIBRATOR, 120V 83-117 VIB
K821633 · Fred Sammons, Inc. · Jun 1982