DANYANG HUAYI K2 AND K7 WHEELCHAIRS— 510(k) K080207

Substantially Equivalent

Danyang Huayi Medical Supply & Equipment Co, Ltd.

FDA 510(k) clearance K080207 for DANYANG HUAYI K2 AND K7 WHEELCHAIRS, Substantially Equivalent on 2008-03-12. Applicant: Danyang Huayi Medical Supply & Equipment Co, Ltd..

Clearance details

Applicant: Danyang Huayi Medical Supply & Equipment Co, Ltd.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2008-01-28
Decision date: 2008-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Potomac, MD, US

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.