Clearance Summary
KLAXON (TWIST); KLAXON (TWIST R) received FDA 510(k) clearance under submission number K250748, sponsored by Klaxon-Mobility GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2025-04-11.
- Submission: K250748
- Applicant / Sponsor: Klaxon-Mobility GmbH
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3860
- Decision date: 2025-04-11
Classification & Regulation
This clearance is catalogued under FDA product code ITI and 21 CFR 890.3860, within the Physical Medicine review panel as a Class II device.