THE TERMINATOR— 510(k) K922535

Substantially Equivalent

Top End Wheelchair Sports, Inc.

FDA 510(k) clearance K922535 for THE TERMINATOR, Substantially Equivalent on 1992-07-24. Applicant: Top End Wheelchair Sports, Inc..

Clearance details

Applicant: Top End Wheelchair Sports, Inc.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 1992-05-28
Decision date: 1992-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pinellas Park, FL, 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.