Cleared Traditional

K950931 - AVON MASSAGING HAIRBRUSH

K950931 is an FDA 510(k) clearance for AVON MASSAGING HAIRBRUSH, manufactured by Siegel,Mandell & Davidson,P.C.. The device is a Class 1 Physical Medicine device with product code ISA cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K950931 · Siegel,Mandell & Davidson,P.C. · Physical Medicine device
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Apr 1995
Decision
35d
Days
Class 1
Risk

K950931 is an FDA 510(k) clearance for the AVON MASSAGING HAIRBRUSH. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Siegel,Mandell & Davidson,P.C. (New York, US). The FDA issued a Cleared decision on April 5, 1995 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5660 - 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 Siegel,Mandell & Davidson,P.C. devices

FDA 510(k) Submission Details - K950931

510(k) Number K950931 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 01, 1995
Decision Date April 05, 1995
Days to Decision 35 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

ISA Device Classification - Class 1, General Controls

Product Code ISA Massager, Therapeutic, Electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5660
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 - ISA Massager, Therapeutic, Electric

All 28
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