MECHANICAL WHEELCHAIR - L-FRAME SERIES— 510(k) K071444

Substantially Equivalent

Colours 'N Motion

FDA 510(k) clearance K071444 for MECHANICAL WHEELCHAIR - L-FRAME SERIES, Substantially Equivalent on 2007-07-27. Applicant: Colours 'N Motion.

Clearance details

Applicant
Colours 'N Motion
Product code
Code IOR
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Corona, CA, US
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.