Cleared Traditional

BODY FLEX

K942950 · Conair Corp. · Physical Medicine
Jul 1994
Decision
33d
Days
Class 1
Risk

About This 510(k) Submission

K942950 is an FDA 510(k) clearance for the BODY FLEX, a Massager, Therapeutic, Electric (Class I — General Controls, product code ISA), submitted by Conair Corp. (Stamford, US). The FDA issued a Cleared decision on July 26, 1994, 33 days after receiving the submission on June 23, 1994. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5660.

Submission Details

510(k) Number K942950 FDA.gov
FDA Decision Cleared SN
Date Received June 23, 1994
Decision Date July 26, 1994
Days to Decision 33 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ISA — Massager, Therapeutic, Electric
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5660