FDA applicant
Otto Bock Healthcare LP
FDA records 17 decisions for Otto Bock Healthcare LP (Minneapolis, MN) from 2003 to 2022: 17 510(k) clearances. Most are in product codes ITI (Wheelchair, Powered) and IOR (Wheelchair, Mechanical). Its devices cite 13 predicates, 4 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Otto Bock Healthcare LP’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Otto Bock Healthcare LP’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Otto”
FDA records each applicant name separately; these may or may not be the same firm.