510(k) K173692

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

K173692 is an FDA 510(k) premarket notification submitted by Storz Medical AG for the device "D-Actor 200 Vibration Massage System". The FDA issued a decision of Substantially Equivalent on April 13, 2018. The device falls under product code ISA (Massager, Therapeutic, Electric), a Class I device regulated under 21 CFR 890.5660. Storz Medical AG has at least 2 other 510(k) clearances on record.

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