K233695
- 510(k) number
- K233695
- Device name
- Medical HAL Lower Limb Type (HAL-ML)
- Applicant
- Cyberdyne, Inc. JP
- Product code
- PHL — Powered Exoskeleton
- Decision date
- 2024-05-07
- Date received
- 2023-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
510(k) Summary (official FDA PDF): K233695.pdf
Official FDA record: K233695
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.