PHL — Powered Exoskeleton Class II
Classification Details
- Product Code
- PHL
- Device Class
- Class II
- Regulation Number
- 890.3480
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Physical Medicine
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250904 | wandercraft | Atalante X | October 24, 2025 |
| K241822 | rewalk robotics ltd. dba lifeward | ReWalk® 7 Personal Exoskeleton (50-20-0005) | March 12, 2025 |
| K233695 | cyberdyne | Medical HAL Lower Limb Type (HAL-ML) | May 7, 2024 |
| K232077 | wandercraft | Atalante X | December 13, 2023 |
| K221696 | re walk robotics | ReWalk P6.0 | March 2, 2023 |
| K221859 | wandercraft | Atalante | December 29, 2022 |
| K220988 | ekso bionics | EksoNR | June 9, 2022 |
| K213452 | samsung electronics co | GEMS-H | April 21, 2022 |
| K201473 | exoatlet asia co. | ExoAtlet-II | July 16, 2021 |
| K201559 | cyberdyne | HAL for Medical Use(Lower Limb type) | October 2, 2020 |
| K201539 | b-temia | Keeogo Dermoskeleton System | September 9, 2020 |
| K200574 | ekso bionics | EksoNR | June 19, 2020 |
| K200032 | re walk robotics | ReWalk P6.0 | May 26, 2020 |
| K190337 | re walk robotics | ReWalk Restore | June 3, 2019 |
| K183152 | us bionics, inc. (dba suitx) | Phoenix | April 17, 2019 |
| K181294 | honda motor company | Honda Walking Assist Device | December 14, 2018 |
| K173530 | parker-hannifin corporation | Indego(R) | January 31, 2018 |
| K171909 | cyberdyne | HAL for Medical Use (Lower Limb Type) | December 17, 2017 |
| K171334 | parker hannifin corporation | Indego | September 8, 2017 |
| K160987 | rewalk robotics | ReWalk(TM) | July 22, 2016 |