HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4— 510(k) K091482
Substantially EquivalentDanyang Huayi Medical Supply & Equipment Co, Ltd.
FDA 510(k) clearance K091482 for HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4, Substantially Equivalent on 2009-07-06. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Decatur, GA, US
Adverse events under product code IOR
product code IOR- Death
- 10
- Injury
- 232
- Other
- 2
- Total
- 244
Source: openFDA MAUDE database, through . 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.