STAGE III— 510(k) K903659

Substantially Equivalent

Unique Flotation Systems, Inc.

FDA 510(k) clearance K903659 for STAGE III, Substantially Equivalent on 1990-09-17. Applicant: Unique Flotation Systems, Inc..

Clearance details

Applicant
Unique Flotation Systems, Inc.
Product code
Code IOQ
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Corona, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code IOQ

product code IOQ
Malfunction
676
Other
5
Total
681

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.