Cleared Traditional

SONASSAGE (K923238) - FDA 510(k) Clearance

Class I Physical Medicine device.

K923238 · Conair Corp. · Physical Medicine device
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Feb 1994
Decision
580d
Days
Class 1
Risk

K923238 is an FDA 510(k) clearance for the SONASSAGE. Classified as Vibrator, Therapeutic (product code IRO), Class I - General Controls.

Submitted by Conair Corp. (Stamford, US). The FDA issued a Cleared decision on February 2, 1994 after a review of 580 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Conair Corp. devices

Submission Details

510(k) Number K923238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1992
Decision Date February 02, 1994
Days to Decision 580 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
465d slower than avg
Panel avg: 115d · This submission: 580d
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 K923238.
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