510(k) K252687— Manual Wheelchair (HM305-Air1, HM305-Air2)

Substantially Equivalent

Suzhou Master Machinery Manufacturing Co.,Ltd

Clearance details

Applicant: Suzhou Master Machinery Manufacturing Co.,Ltd
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2025-08-26
Decision date: 2025-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kunshan, 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.