K250904
- 510(k) number
- K250904
- Device name
- Atalante X
- Applicant
- Wandercraft SAS FR
- Product code
- PHL — Powered Exoskeleton
- Decision date
- 2025-10-24
- Date received
- 2025-03-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K250904.pdf
Official FDA record: K250904
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.