Cleared Traditional

BODY RELAXER

K926339 · Conair Corp. · Physical Medicine
Mar 1994
Decision
444d
Days
Class 1
Risk

About This 510(k) Submission

K926339 is an FDA 510(k) clearance for the BODY RELAXER, a Massager, Therapeutic, Electric (Class I — General Controls, product code ISA), submitted by Conair Corp. (Stamford, US). The FDA issued a Cleared decision on March 4, 1994, 444 days after receiving the submission on December 15, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5660.

Submission Details

510(k) Number K926339 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 1992
Decision Date March 04, 1994
Days to Decision 444 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

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