Cleared Traditional

CONAIR FAMILY FITNESS BODY ENERGY

K950441 · Conair Corp. · Physical Medicine
Jul 1995
Decision
172d
Days
Class 1
Risk

About This 510(k) Submission

K950441 is an FDA 510(k) clearance for the CONAIR FAMILY FITNESS BODY ENERGY, a Vibrator, Therapeutic (Class I — General Controls, product code IRO), submitted by Conair Corp. (Stamford, US). The FDA issued a Cleared decision on July 18, 1995, 172 days after receiving the submission on January 27, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5975.

Submission Details

510(k) Number K950441 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 1995
Decision Date July 18, 1995
Days to Decision 172 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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