PHL — Powered Exoskeleton Class II
FDA product code PHL covers "Powered Exoskeleton", a Class II medical device regulated under 21 CFR 890.3480. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |