Cleared Traditional

BODY RECHARGER

K940369 · Conair Corp. · Physical Medicine
Apr 1994
Decision
85d
Days
Class 1
Risk

About This 510(k) Submission

K940369 is an FDA 510(k) clearance for the BODY RECHARGER, a Massager, Therapeutic, Electric (Class I — General Controls, product code ISA), submitted by Conair Corp. (Stamford, US). The FDA issued a Cleared decision on April 21, 1994, 85 days after receiving the submission on January 26, 1994. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5660.

Submission Details

510(k) Number K940369 FDA.gov
FDA Decision Cleared SN
Date Received January 26, 1994
Decision Date April 21, 1994
Days to Decision 85 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