K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR))— 510(k) K260319

Substantially Equivalent

Zhenjiang Assure Medical Equipment Co., Ltd.

FDA 510(k) clearance K260319 for K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR)), Substantially Equivalent on 2026-03-31. Applicant: 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: 2026-01-30
Decision date: 2026-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhenjiang, 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.