Cleared Traditional

FAMILY FITNESS SHIATSU MASSAGER

K943092 · Conair Corp. · Physical Medicine
Sep 1994
Decision
93d
Days
Class 1
Risk

About This 510(k) Submission

K943092 is an FDA 510(k) clearance for the FAMILY FITNESS SHIATSU MASSAGER, a Massager, Therapeutic, Electric (Class I — General Controls, product code ISA), submitted by Conair Corp. (Stamford, US). The FDA issued a Cleared decision on September 29, 1994, 93 days after receiving the submission on June 28, 1994. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5660.

Submission Details

510(k) Number K943092 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 1994
Decision Date September 29, 1994
Days to Decision 93 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