D-Actor 200 Vibration Massage System— 510(k) K173692

Substantially Equivalent

Storz Medical AG

FDA 510(k) clearance K173692 for D-Actor 200 Vibration Massage System, Substantially Equivalent on 2018-04-13. Applicant: Storz Medical AG. Device class: 1.

Clearance details

Applicant
Storz Medical AG
Product code
Code ISA
Device class
Class 1
Regulation
21 CFR 890.5660
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tagerwilen, CH
Download summary PDFView on FDA.gov ↗

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Adverse events under product code ISA

product code ISA
Death
3
Other
1
Total
4

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.