Powered Exoskeleton
The Powered Exoskeleton is a prescription motorized orthotic device that is placed over a person's paralyzed or weakened lower extremity limb(s) to assist with mobility and rehabilitation for medical purposes. It is an FDA Class 2 device regulated under 21 CFR 890.3480, requiring 510(k) premarket notification, within the Physical Medicine (PM) specialty with Neurology (NE) panel review. The product code is PHL. This device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PHL
- Device Class
- FDA class 2
- Regulation Number
- 890.3480
- Medical Specialty
- Physical Medicine
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
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) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 24 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250904 | Atalante X | Oct 24, 2025 | Substantially Equivalent | Wandercraft SAS |
| K241822 | ReWalk® 7 Personal Exoskeleton (50-20-0005) | Mar 12, 2025 | Substantially Equivalent | Rewalk Robotics Ltd. Dba Lifeward |
| K233695 | Medical HAL Lower Limb Type (HAL-ML) | May 07, 2024 | Substantially Equivalent | Cyberdyne, Inc. |
| K232077 | Atalante X | Dec 13, 2023 | Substantially Equivalent | Wandercraft SAS |
| K221696 | ReWalk P6.0 | Mar 02, 2023 | Substantially Equivalent | Re Walk Robotics , Ltd. |
| K221859 | Atalante | Dec 29, 2022 | Substantially Equivalent | Wandercraft SAS |
| K220988 | EksoNR | Jun 09, 2022 | Substantially Equivalent | Ekso Bionics, Inc. |
| K213452 | GEMS-H | Apr 21, 2022 | Substantially Equivalent | Samsung Electronics Co., Ltd. |
| K201473 | ExoAtlet-II | Jul 16, 2021 | Substantially Equivalent | Exoatlet Asia Co. , Ltd. |
| K201559 | HAL for Medical Use(Lower Limb type) | Oct 02, 2020 | Substantially Equivalent | Cyberdyne, Inc. |
| K201539 | Keeogo Dermoskeleton System | Sep 09, 2020 | Substantially Equivalent | B-Temia, Inc. |
| K200574 | EksoNR | Jun 19, 2020 | Substantially Equivalent | Ekso Bionics, Inc. |
| K200032 | ReWalk P6.0 | May 26, 2020 | Substantially Equivalent | Re Walk Robotics , Ltd. |
| K190337 | ReWalk Restore | Jun 03, 2019 | Substantially Equivalent | Re Walk Robotics , Ltd. |
| K183152 | Phoenix | Apr 17, 2019 | Substantially Equivalent | Us Bionics, Inc. (Dba Suitx) |
| K181294 | Honda Walking Assist Device | Dec 14, 2018 | Substantially Equivalent | Honda Motor Company, Ltd. |
| K173530 | Indego(R) | Jan 31, 2018 | Substantially Equivalent | Parker-Hannifin Corporation |
| K171909 | HAL for Medical Use (Lower Limb Type) | Dec 17, 2017 | Substantially Equivalent | Cyberdyne, Inc. |
| K171334 | Indego | Sep 08, 2017 | Substantially Equivalent | Parker Hannifin Corporation |
| K160987 | ReWalk(TM) | Jul 22, 2016 | Substantially Equivalent | Rewalk Robotics, Inc. |
| K161443 | Ekso (version 1.1) and Ekso GT (version 1.2) | Jul 19, 2016 | Substantially Equivalent | Ekso Bionics, Inc. |
| K143690 | Ekso (version 1.1) and Ekso GT (version 1.2) | Apr 01, 2016 | Substantially Equivalent | Ekso Bionics, Inc. |
| K152416 | Indego | Feb 26, 2016 | Substantially Equivalent | Parker Hannifin Corporation |
| DEN130034 | REWALK | Jun 26, 2014 | Unknown | Argo Medical Technologies, Inc. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.