MA012 Aluminum wheelchair, MS019 steel wheelchair— 510(k) K231750

Substantially Equivalent

Sichuan Ast Medical Equipment Co., Ltd.

FDA 510(k) clearance K231750 for MA012 Aluminum wheelchair, MS019 steel wheelchair, Substantially Equivalent on 2023-08-15. Applicant: Sichuan Ast Medical Equipment Co., Ltd..

Clearance details

Applicant: Sichuan Ast Medical Equipment Co., Ltd.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2023-06-15
Decision date: 2023-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Luzhou, 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.