PHL
- Product code
- PHL
- Device name
- Powered Exoskeleton
- Device class
- Class 2
- 21 CFR
- 21 CFR 890.3480
- Medical specialty
- Physical Medicine
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 25 (all years; only the last 3 years are listed here)
FDA classification definition
A powered exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened lower extremity limb(s) for medical purposes.
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260381 | 2026-08-03 | Wandercraft SAS | Eve | |
| K250904 | 2025-10-24 | Wandercraft SAS | Atalante X | |
| K241822 | 2025-03-12 | Rewalk Robotics Ltd. Dba Lifeward | ReWalk® 7 Personal Exoskeleton (50-20-0005) | |
| K233695 | 2024-05-07 | Cyberdyne, Inc. | Medical HAL Lower Limb Type (HAL-ML) | FDA |
| K232077 | 2023-12-13 | Wandercraft SAS | Atalante X |
Official FDA classification page: PHL
Classification and pathway per current FDA publications. Data from openFDA (CC0).