Cleared Traditional

WM10, WM20, WM30 POWER MASSAGER

K862041 · Associated Mills, Inc. · Physical Medicine
Jun 1986
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K862041 is an FDA 510(k) clearance for the WM10, WM20, WM30 POWER MASSAGER, a Massager, Therapeutic, Electric (Class I — General Controls, product code ISA), submitted by Associated Mills, Inc. (Chicago, US). The FDA issued a Cleared decision on June 17, 1986, 20 days after receiving the submission on May 28, 1986. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5660.

Submission Details

510(k) Number K862041 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 1986
Decision Date June 17, 1986
Days to Decision 20 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