Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE— 510(k) K111278
Substantially EquivalentOtto Bock Healthcare LP
FDA 510(k) clearance K111278 for Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE, Substantially Equivalent on 2011-09-16. Applicant: Otto Bock Healthcare LP.
Clearance details
- Applicant
- Otto Bock Healthcare LP
- Product code
- Code ITI
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Adverse events under product code ITI
product code ITI- Death
- 34
- Injury
- 778
- Malfunction
- 1,085
- Other
- 1
- Total
- 1,898
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.