WHEELCHAIR CONVERSION KIT— 510(k) K904650

Substantially Equivalent

Hadco Marketing Services, Inc.

FDA 510(k) clearance K904650 for WHEELCHAIR CONVERSION KIT, Substantially Equivalent on 1991-05-21. Applicant: Hadco Marketing Services, Inc..

Clearance details

Applicant
Hadco Marketing Services, Inc.
Product code
Code ITI
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ft. Lauderdale, FL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code ITI

product code ITI
Death
34
Injury
778
Malfunction
1,085
Other
1
Total
1,898

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.