Powered Exoskeleton
FDA product code PHL · Class II (moderate risk) · 21 CFR 890.3480 · Physical Medicine
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.
25510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Ekso Bionics, Inc. 4
- Wandercraft SAS 4
- Parker Hannifin Corp. 3
- Cyberdyne, Inc. 3
- Re Walk Robotics , Ltd. 3
- Rewalk Robotics, Inc. 1
- Honda Motor Company, Ltd. 1
- Us Bionics, Inc. (Dba Suitx) 1
- B-Temia, Inc. 1
- Exoatlet Asia Co. , Ltd. 1
- Samsung Electronics Co., Ltd. 1
- Rewalk Robotics Ltd. Dba Lifeward 1
- Trexo Robotics, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254198 | Trexo TheoPHL · Traditional | Trexo Robotics, Inc. | 09/02/2026SE |
| K260381 | EvePHL · Traditional | Wandercraft SAS | 08/03/2026SE |
| K250904 | Atalante XPHL · Traditional | Wandercraft SAS | 10/24/2025SE |
| K241822 | ReWalk® 7 Personal Exoskeleton (50-20-0005)PHL · Traditional | Rewalk Robotics Ltd. Dba Lifeward | 03/12/2025SE |
| K233695 | Medical HAL Lower Limb Type (HAL-ML)PHL · Traditional | Cyberdyne, Inc. | 05/07/2024SE |
| K232077 | Atalante XPHL · Traditional | Wandercraft SAS | 12/13/2023SE |
| K221696 | ReWalk P6.0PHL · Traditional | Re Walk Robotics , Ltd. | 03/02/2023SE |
| K221859 | AtalantePHL · Traditional | Wandercraft SAS | 12/29/2022SE |
| K220988 | EksoNRPHL · Traditional | Ekso Bionics, Inc. | 06/09/2022SE |
| K213452 | Gems-HPHL · Traditional | Samsung Electronics Co., Ltd. | 04/21/2022SE |
| K201473 | ExoAtlet-IIPHL · Traditional | Exoatlet Asia Co. , Ltd. | 07/16/2021SE |
| K201559 | HAL for Medical Use(Lower Limb type)PHL · Traditional | Cyberdyne, Inc. | 10/02/2020SE |
| K201539 | Keeogo Dermoskeleton SystemPHL · Traditional | B-Temia, Inc. | 09/09/2020SE |
| K200574 | EksoNRPHL · Traditional | Ekso Bionics, Inc. | 06/19/2020SE |
| K200032 | ReWalk P6.0PHL · Traditional | Re Walk Robotics , Ltd. | 05/26/2020SE |
| K190337 | ReWalk RestorePHL · Traditional | Re Walk Robotics , Ltd. | 06/03/2019SE |
| K183152 | PhoenixPHL · Traditional | Us Bionics, Inc. (Dba Suitx) | 04/17/2019SE |
| K181294 | Honda Walking Assist DevicePHL · Traditional | Honda Motor Company, Ltd. | 12/14/2018SE |
| K173530 | Indego(R)PHL · Traditional | Parker-Hannifin Corporation | 01/31/2018SE |
| K171909 | HAL for Medical Use (Lower Limb Type)PHL · Traditional | Cyberdyne, Inc. | 12/17/2017SE |
| K171334 | IndegoPHL · Traditional | Parker Hannifin Corporation | 09/08/2017SE |
| K160987 | ReWalk(TM)PHL · Special | Rewalk Robotics, Inc. | 07/22/2016SE |
| K161443 | Ekso (version 1.1) and Ekso GT (version 1.2)PHL · Traditional | Ekso Bionics, Inc. | 07/19/2016SE |
| K143690 | Ekso (version 1.1) and Ekso GT (version 1.2)PHL · Traditional | Ekso Bionics, Inc. | 04/01/2016SE |
| K152416 | IndegoPHL · Traditional | Parker Hannifin Corporation | 02/26/2016SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1739-2025 Class II | Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions…Potential for exoskeleton to lose lateral balance and cause patient to fall. | Wandercraft SAS | 04/03/2025Open, Classified |
| Z-1553-2021 Class II | ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the…ReWalk Robotics received two complaints (one in the US; one in the Germany), which alleged that the ReWalk… | Argo Medical Technologies Ltd | 02/28/2020Terminated |
| Z-0944-2018 Class II | ReWalk Personal 6.0. Catalog number: 50-20-0004.Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula. | Argo Medical Technologies Ltd | 08/14/2017Terminated |