K241159
- 510(k) number
- K241159
- Device name
- Handbike Batec Electric
- Applicant
- Batec Mobility, S.L. ES
- Product code
- ITI — Wheelchair, Powered
- Decision date
- 2025-03-07
- Date received
- 2024-04-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K241159.pdf
Official FDA record: K241159
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.