Cleared Traditional

BODY SOOTHER

K924518 · Conair Corp. · Physical Medicine
Oct 1993
Decision
403d
Days
Class 1
Risk

About This 510(k) Submission

K924518 is an FDA 510(k) clearance for the BODY SOOTHER, a Massager, Therapeutic, Electric (Class I — General Controls, product code ISA), submitted by Conair Corp. (Stamford, US). The FDA issued a Cleared decision on October 12, 1993, 403 days after receiving the submission on September 4, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5660.

Submission Details

510(k) Number K924518 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 1992
Decision Date October 12, 1993
Days to Decision 403 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