QUICKIE & ZIPPIE SERIES— 510(k) K123975

Substantially Equivalent

Sunrise Medical

FDA 510(k) clearance K123975 for QUICKIE & ZIPPIE SERIES, Substantially Equivalent on 2013-08-16. Applicant: Sunrise Medical.

Clearance details

Applicant
Sunrise Medical
Product code
Code IOR
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fresno, 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.