AST Model MA012 and MS019 Rehab Wheelchair— 510(k) K181795

Substantially Equivalent

Sichuan Ast Medical Equipment Co., Ltd.

FDA 510(k) clearance K181795 for AST Model MA012 and MS019 Rehab Wheelchair, Substantially Equivalent on 2018-09-25. 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: 2018-07-05
Decision date: 2018-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Luzhou City, 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.