Manual Wheelchair (SYIV100-CA9221)— 510(k) K242560

Substantially Equivalent

Foshan Shunkangda Medical Tech Co., Ltd.

FDA 510(k) clearance K242560 for Manual Wheelchair (SYIV100-CA9221), Substantially Equivalent on 2024-10-24. Applicant: Foshan Shunkangda Medical Tech Co., Ltd..

Clearance details

Applicant: Foshan Shunkangda Medical Tech Co., Ltd.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2024-08-28
Decision date: 2024-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foshan, CN

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.