510(k) K173692

D-Actor 200 Vibration Massage System by Storz Medical AG — Product Code ISA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2018
Date Received
December 1, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Therapeutic, Electric
Device Class
Class I
Regulation Number
890.5660
Review Panel
PM
Submission Type