FDA applicant
Klaxon Mobility GmbH
FDA records 3 decisions for Klaxon Mobility GmbH (Arnoldstein, AT) from 2022 to 2025: 3 510(k) clearances. All are in product code ITI (Wheelchair, Powered). Since 2016 its 510(k)s took a median of 120 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Klaxon-Mobility GmbH”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Klaxon Mobility GmbH’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Klaxon Mobility GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report