Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12)— 510(k) K240079

Substantially Equivalent

Suzhou Ideal Medical Co., Ltd.

FDA 510(k) clearance K240079 for Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12), Substantially Equivalent on 2024-08-09. Applicant: Suzhou Ideal Medical Co., Ltd..

Clearance details

Applicant
Suzhou Ideal Medical Co., Ltd.
Product code
Code ITI
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Suzhou, CN
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.