ARTISAN FOLDING WHEELCHAIRS— 510(k) K844799

Substantially Equivalent

Artisan Wheel Chair Manufacturers

FDA 510(k) clearance K844799 for ARTISAN FOLDING WHEELCHAIRS, Substantially Equivalent on 1985-03-05. Applicant: Artisan Wheel Chair Manufacturers.

Clearance details

Applicant
Artisan Wheel Chair Manufacturers
Product code
Code IOR
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Shu Lin, Taipei Hsien, TW
Download summary PDFView on FDA.gov ↗

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.