K250748
- 510(k) number
- K250748
- Device name
- KLAXON (TWIST); KLAXON (TWIST R)
- Applicant
- Klaxon-Mobility GmbH AT
- Product code
- ITI — Wheelchair, Powered
- Decision date
- 2025-04-11
- Date received
- 2025-03-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250748.pdf
Official FDA record: K250748
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.