Cleared Traditional

FAMILY FITNESS SHIATSU MASSAGER

K944637 · Conair Corp. · Physical Medicine
Dec 1994
Decision
83d
Days
Class 1
Risk

About This 510(k) Submission

K944637 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 December 13, 1994, 83 days after receiving the submission on September 21, 1994. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5660.

Submission Details

510(k) Number K944637 FDA.gov
FDA Decision Cleared SN
Date Received September 21, 1994
Decision Date December 13, 1994
Days to Decision 83 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