510(k) K261075— Manual Wheelchair (MS01);Manual Wheelchair (MA01)

Substantially Equivalent

GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.

Clearance details

Applicant: GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2026-04-01
Decision date: 2026-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhongshan, CN

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.