BRODA WHEELCHAIR— 510(k) K905671

Substantially Equivalent

Broda Ent., Inc.

FDA 510(k) clearance K905671 for BRODA WHEELCHAIR, Substantially Equivalent on 1990-12-31. Applicant: Broda Ent., Inc..

Clearance details

Applicant: Broda Ent., Inc.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 1990-12-18
Decision date: 1990-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario, Canada, CA

Download summary PDF View on FDA.gov ↗

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.