START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI)— 510(k) K052681

Substantially Equivalent

Otto Bock Healthcare LP

FDA 510(k) clearance K052681 for START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI), Substantially Equivalent on 2005-10-06. Applicant: Otto Bock Healthcare LP.

Clearance details

Applicant: Otto Bock Healthcare LP
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2005-09-28
Decision date: 2005-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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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.