Manual Wheelchair (SYIV100A008)— 510(k) K252517

Substantially Equivalent

Ningbo Shenyu Medical Equipment Co.,Ltd

FDA 510(k) clearance K252517 for Manual Wheelchair (SYIV100A008), Substantially Equivalent on 2025-10-03. Applicant: 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: 2025-08-11
Decision date: 2025-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yuyao, 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.