FDA Product Code PHL: Powered Exoskeleton
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.
Leading manufacturers include Re Walk Robotics , Ltd., Wandercraft SAS and Ekso Bionics, Inc..
24
Total
23
Cleared
183d
Avg days
2014
Since
Declining activity -
2 submissions in the last 2 years
vs 4 in the prior period
Review times increasing: avg
237d
recently vs 178d historically
FDA 510(k) Cleared Powered Exoskeleton Devices (Product Code PHL)
24 devices
Cleared
Oct 24, 2025
Atalante X
Wandercraft SAS
Neurology
212d
Cleared
Mar 12, 2025
ReWalk® 7 Personal Exoskeleton (50-20-0005)
Rewalk Robotics Ltd. Dba Lifeward
Neurology
261d
Cleared
May 07, 2024
Medical HAL Lower Limb Type (HAL-ML)
Cyberdyne, Inc.
Neurology
172d
Cleared
Dec 13, 2023
Atalante X
Wandercraft SAS
Neurology
153d
Cleared
Mar 02, 2023
ReWalk P6.0
Re Walk Robotics , Ltd.
Neurology
265d
Cleared
Dec 29, 2022
Atalante
Wandercraft SAS
Neurology
185d
Cleared
Jun 09, 2022
EksoNR
Ekso Bionics, Inc.
Neurology
66d
Cleared
Apr 21, 2022
GEMS-H
Samsung Electronics Co., Ltd.
Neurology
177d
Cleared
Jul 16, 2021
ExoAtlet-II
Exoatlet Asia Co. , Ltd.
Neurology
408d
Cleared
Oct 02, 2020
HAL for Medical Use(Lower Limb type)
Cyberdyne, Inc.
Neurology
114d
Cleared
Sep 09, 2020
Keeogo Dermoskeleton System
B-Temia, Inc.
Neurology
92d
Cleared
Jun 19, 2020
EksoNR
Ekso Bionics, Inc.
Neurology
106d
Cleared
May 26, 2020
ReWalk P6.0
Re Walk Robotics , Ltd.
Neurology
140d
Cleared
Jun 03, 2019
ReWalk Restore
Re Walk Robotics , Ltd.
Neurology
109d
Cleared
Apr 17, 2019
Phoenix
Us Bionics, Inc. (Dba Suitx)
Physical Medicine
154d
Cleared
Dec 14, 2018
Honda Walking Assist Device
Honda Motor Company, Ltd.
Neurology
212d
Cleared
Jan 31, 2018
Indego(R)
Parker Hannifin Corporation
Neurology
77d
About Product Code PHL - Regulatory Context
510(k) Submission Activity
24 total 510(k) submissions under product code PHL since 2014, with 23 receiving FDA clearance (average review time: 183 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 4 in the prior period.
FDA 510(k) Review Time - PHL Product Code
Recent submissions under PHL have taken an average of 237 days to reach a decision - up from 178 days historically. Manufacturers should account for longer review timelines in current project planning.
PHL devices are reviewed by the Neurology panel. Browse all Neurology devices →