JEWEL MPS— 510(k) K011374

Substantially Equivalent

Vestil Manufacturing Corp.

FDA 510(k) clearance K011374 for JEWEL MPS, Substantially Equivalent on 2001-05-29. Applicant: Vestil Manufacturing Corp..

Clearance details

Applicant
Vestil Manufacturing Corp.
Product code
Code IOR
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Angola, IN, 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.