510(k) K201461— Manual Wheelchair, Model A011

Substantially Equivalent

Ningbo Shenyu Medical Equipment Co.,Ltd

Clearance details

Applicant: Ningbo Shenyu Medical Equipment Co.,Ltd
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2020-06-02
Decision date: 2021-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yuyao, 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.