510(k) K232198— Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S 20D, YJ-011S 20DF)

Substantially Equivalent

Zhenjiang Assure Medical Equipment Co., Ltd.

Clearance details

Applicant: Zhenjiang Assure Medical Equipment Co., Ltd.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2023-07-25
Decision date: 2023-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhenjiang City, 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.