Cleared Traditional

BODY SYSTEM

K942223 · Conair Corp. · Physical Medicine
Jun 1994
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K942223 is an FDA 510(k) clearance for the BODY SYSTEM, a Massager, Therapeutic, Electric (Class I — General Controls, product code ISA), submitted by Conair Corp. (Stamford, US). The FDA issued a Cleared decision on June 9, 1994, 34 days after receiving the submission on May 6, 1994. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5660.

Submission Details

510(k) Number K942223 FDA.gov
FDA Decision Cleared SN
Date Received May 06, 1994
Decision Date June 09, 1994
Days to Decision 34 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