510(k) K250748— KLAXON (TWIST); KLAXON (TWIST R)

Substantially Equivalent

Klaxon-Mobility GmbH

Clearance details

Applicant: Klaxon-Mobility GmbH
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2025-03-12
Decision date: 2025-04-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Arnoldstein, AT

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.