PADPRO, MODEL 2502— 510(k) K020743

Substantially Equivalent

Padpro, LLC

FDA 510(k) clearance K020743 for PADPRO, MODEL 2502, Substantially Equivalent on 2002-05-28. Applicant: Padpro, LLC.

Clearance details

Applicant
Padpro, LLC
Product code
Code MKJ
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Deer Field, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code MKJ

product code MKJ
Death
961
Injury
1,070
Malfunction
90,719
Other
8
Total
92,758

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.