D-Actor 200 Vibration Massage System

Massager, Therapeutic, Electric

Storz Medical AG

The following data is part of a premarket notification filed by Storz Medical Ag with the FDA for D-actor 200 Vibration Massage System.

Pre-market Notification Details

Device IDK173692
510k NumberK173692
Device Name:D-Actor 200 Vibration Massage System
ClassificationMassager, Therapeutic, Electric
Applicant Storz Medical AG Lohstampfestrasse 8 Tägerwilen,  CH Ch-8274
ContactPavel Novak
CorrespondentMichael Dayton
Biomed Research, Inc. 3959 Van Dyke Road Suite 245 Lutz,  FL  33558
Product CodeISA  
CFR Regulation Number890.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-01
Decision Date2018-04-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630039101121 K173692 000
07630039101060 K173692 000
07630039101039 K173692 000
07630039101008 K173692 000
07630039101169 K173692 000
07630039101343 K173692 000
07630039101404 K173692 000
07630039101817 K173692 000

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