K241822
- 510(k) number
- K241822
- Device name
- ReWalk® 7 Personal Exoskeleton (50-20-0005)
- Applicant
- Rewalk Robotics Ltd. Dba Lifeward IL
- Product code
- PHL — Powered Exoskeleton
- Decision date
- 2025-03-12
- Date received
- 2024-06-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K241822.pdf
Official FDA record: K241822
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.