FORTRESS 1600ACV REAR WHEEL DRIVE SCOOTER— 510(k) K910751

Substantially Equivalent

Fortress Litestyle

FDA 510(k) clearance K910751 for FORTRESS 1600ACV REAR WHEEL DRIVE SCOOTER, Substantially Equivalent on 1991-04-22. Applicant: Fortress Litestyle.

Clearance details

Applicant
Fortress Litestyle
Product code
Code INI
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Washington, DC, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code INI

product code INI
Injury
171
Other
1
Total
172

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.