LERADO AVANTICARE POWER WHEELCHAIR, MODEL PW-1800— 510(k) K050087

Substantially Equivalent

Lerado Oversea Ltd. Twn Branch (Bvi)

FDA 510(k) clearance K050087 for LERADO AVANTICARE POWER WHEELCHAIR, MODEL PW-1800, Substantially Equivalent on 2005-02-01. Applicant: Lerado Oversea Ltd. Twn Branch (Bvi).

Clearance details

Applicant
Lerado Oversea Ltd. Twn Branch (Bvi)
Product code
Code ITI
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hsin-Chu City, TW
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.