Cleared Traditional

D-Actor 200 Vibration Massage System

K173692 · Storz Medical AG · Physical Medicine
Apr 2018
Decision
133d
Days
Class 1
Risk

About This 510(k) Submission

K173692 is an FDA 510(k) clearance for the D-Actor 200 Vibration Massage System, a Massager, Therapeutic, Electric (Class I — General Controls, product code ISA), submitted by Storz Medical AG (Tagerwilen, CH). The FDA issued a Cleared decision on April 13, 2018, 133 days after receiving the submission on December 1, 2017. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5660.

Submission Details

510(k) Number K173692 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 2017
Decision Date April 13, 2018
Days to Decision 133 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code ISA — Massager, Therapeutic, Electric
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5660