K110985

Substantially Equivalent

ICON ADULT MANUAL

Applicant: Icon Wheelchairs, Inc.
Product code: IOR
Advisory panel: Physical Medicine
Date received: 2011-04-08
Decision date: 2011-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northampton, MA, 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.