BRODA MODEL 587 MANUAL WHEELCHAIR— 510(k) K032133

Name: FDA 510(k) clearance K032133
Creator: U.S. Food and Drug Administration
Published: 2003-07-21

Substantially Equivalent

Broda Ent., Inc.

FDA 510(k) clearance K032133 for BRODA MODEL 587 MANUAL WHEELCHAIR, Substantially Equivalent on 2003-07-21. Applicant: Broda Ent., Inc.. Device class: 1.

Clearance details

Applicant: Broda Ent., Inc.
Product code: Code IOR
Device class: Class 1
Regulation: 21 CFR 890.3850
Advisory panel: Physical Medicine
Date received: 2003-07-11
Decision date: 2003-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waterloo Ontario, CA

Download summary PDF View on FDA.gov ↗

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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.