TIPOWER POWERDRIVE AND RIMPOWER X & SX— 510(k) K020539

Substantially Equivalent

Tisport

FDA 510(k) clearance K020539 for TIPOWER POWERDRIVE AND RIMPOWER X & SX, Substantially Equivalent on 2002-06-20. Applicant: Tisport.

Clearance details

Applicant: Tisport
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2002-02-19
Decision date: 2002-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kennewick, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITI

product code ITI

Death: 34
Injury: 778
Malfunction: 1,085
Other: 1
Total: 1,898

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.