K113164

Substantially Equivalent

DISCOVERY TMAX MANUAL WHEELCHAIR

Applicant: Otto Bock Healthcare LP
Product code: IOR
Advisory panel: Physical Medicine
Date received: 2011-10-26
Decision date: 2013-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.