Cleared Traditional

CONAIR BODY AND SOLE

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

About This 510(k) Submission

K950410 is an FDA 510(k) clearance for the CONAIR BODY AND SOLE, a Vibrator, Therapeutic (Class I — General Controls, product code IRO), submitted by Conair Corp. (Stamford, US). The FDA issued a Cleared decision on May 23, 1995, 112 days after receiving the submission on January 31, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5975.

Submission Details

510(k) Number K950410 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code IRO — Vibrator, Therapeutic
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5975

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