Cleared Traditional

K950410 - CONAIR BODY AND SOLE

K950410 is an FDA 510(k) clearance for CONAIR BODY AND SOLE, manufactured by Conair Corp.. The device is a Class 1 Physical Medicine device with product code IRO cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K950410 · Conair Corp. · Physical Medicine device
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May 1995
Decision
112d
Days
Class 1
Risk

K950410 is an FDA 510(k) clearance for the CONAIR BODY AND SOLE. Classified as Vibrator, Therapeutic (product code IRO), Class I - General Controls.

Submitted by Conair Corp. (Stamford, US). The FDA issued a Cleared decision on May 23, 1995 after a review of 112 days - within the typical 510(k) review window.

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 Conair Corp. devices

FDA 510(k) Submission Details - K950410

510(k) Number K950410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1995
Decision Date May 23, 1995
Days to Decision 112 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
3d faster than avg
Panel avg: 115d · This submission: 112d
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 21
Devices cleared under the same product code (IRO) and FDA review panel - the closest regulatory comparables to K950410.
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