K002317
Substantially EquivalentMODEL 9000 BARIATRIC WHEELCHAIR
- Applicant
- Invacare Corp.
- Product code
- IOR
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elyria, OH, US
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.