DeviceClearance

K200715

Substantially Equivalent

RoughRider Aurora Manual Wheelchair

Applicant
Roughrider America, LLC
Product code
IOR
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Berkley, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code IOR

product code IOR
Death
10
Injury
232
Other
2
Total
244

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.