CHAMPION, 1000— 510(k) K953429

Substantially Equivalent

Kuschall of America

FDA 510(k) clearance K953429 for CHAMPION, 1000, Substantially Equivalent on 1995-07-31. Applicant: Kuschall of America.

Clearance details

Applicant: Kuschall of America
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 1995-07-20
Decision date: 1995-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camarillo, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.