GEN_2 and GEN_3 Mechanical Wheelchairs— 510(k) K170701
Substantially EquivalentFree Wheelchair Mission
FDA 510(k) clearance K170701 for GEN_2 and GEN_3 Mechanical Wheelchairs, Substantially Equivalent on 2017-03-24. Applicant: Free Wheelchair Mission.
Clearance details
- Applicant
- Free Wheelchair Mission
- Product code
- Code IOR
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, CA, 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.