K101217

Substantially Equivalent

MAC-MOBILE AQUATIC CHAIR

Applicant: Rehamed Intl., LLC
Product code: IOR
Advisory panel: Physical Medicine
Date received: 2010-04-30
Decision date: 2010-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Homestead, FL, 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.