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

Name: FDA 510(k) clearance K250748
Creator: U.S. Food and Drug Administration
Published: 2025-04-11

Substantially Equivalent

Klaxon-Mobility GmbH

FDA 510(k) clearance K250748 for KLAXON (TWIST); KLAXON (TWIST R), Substantially Equivalent on 2025-04-11. Applicant: Klaxon-Mobility GmbH. Device class: 2.

Clearance details

Applicant: Klaxon-Mobility GmbH
Product code: Code ITI
Device class: Class 2
Regulation: 21 CFR 890.3860
Advisory panel: Physical Medicine
Date received: 2025-03-12
Decision date: 2025-04-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Arnoldstein, AT

Download summary PDF View on FDA.gov ↗

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More clearances from Klaxon-Mobility GmbH

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K240267 — Klaxon (Twist); Klaxon (Twist R)2025-01-10
K222502 — KLICK (VARIANTS: POWER, RACE, MONSTER)2022-12-16

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.