24 WIDEN WHEELCHAIR (JY/CT-H28), 18 RECLINING WHEELCHAIR (JY-260), 18 LIGHT WEIGHT WHEELCHAIR (JY/CT-H06), 18 ALUMIN— 510(k) K102110

Substantially Equivalent

Foshan Shunde Jaeyong Hardware Co., Ltd.

FDA 510(k) clearance K102110 for 24 WIDEN WHEELCHAIR (JY/CT-H28), 18 RECLINING WHEELCHAIR (JY-260), 18 LIGHT WEIGHT WHEELCHAIR (JY/CT-H06), 18 ALUMIN, Substantially Equivalent on 2010-10-26. Applicant: Foshan Shunde Jaeyong Hardware Co., Ltd..

Clearance details

Applicant: Foshan Shunde Jaeyong Hardware Co., Ltd.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2010-07-28
Decision date: 2010-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenwood Village, CO, US

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.