Cleared Traditional

WAHL(R) ULTRA COMFORT MASSAGER SPEC #89ISA

K940683 · Wahl Clipper Corp. · Physical Medicine
Jun 1994
Decision
119d
Days
Class 1
Risk

About This 510(k) Submission

K940683 is an FDA 510(k) clearance for the WAHL(R) ULTRA COMFORT MASSAGER SPEC #89ISA, a Massager, Therapeutic, Electric (Class I — General Controls, product code ISA), submitted by Wahl Clipper Corp. (Sterling, US). The FDA issued a Cleared decision on June 9, 1994, 119 days after receiving the submission on February 10, 1994. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5660.

Submission Details

510(k) Number K940683 FDA.gov
FDA Decision Cleared SN
Date Received February 10, 1994
Decision Date June 09, 1994
Days to Decision 119 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