WHEELCHAIR, MODEL 8500-II— 510(k) K043332

Substantially Equivalent

Cycling and Health Tech. Industry R&D Center

FDA 510(k) clearance K043332 for WHEELCHAIR, MODEL 8500-II, Substantially Equivalent on 2004-12-13. Applicant: Cycling and Health Tech. Industry R&D Center.

Clearance details

Applicant: Cycling and Health Tech. Industry R&D Center
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2004-12-02
Decision date: 2004-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung, TW

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.