PHL · Class II · 21 CFR 890.3480

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 Wandercraft SAS, Ekso Bionics, Inc. and Re Walk Robotics , Ltd..

25
Total
24
Cleared
182d
Avg days
2014
Since
Declining activity - 3 submissions in the last 2 years vs 4 in the prior period
Review times increasing: avg 217d recently vs 178d historically

FDA 510(k) Cleared Powered Exoskeleton Devices (Product Code PHL)

25 devices
1–24 of 25
Cleared Aug 03, 2026
Eve
K260381
Wandercraft SAS
Neurology · 179d
Cleared Oct 24, 2025
Atalante X
K250904
Wandercraft SAS
Neurology · 212d
Cleared Mar 12, 2025
ReWalk® 7 Personal Exoskeleton (50-20-0005)
K241822
Rewalk Robotics Ltd. Dba Lifeward
Neurology · 261d
Cleared May 07, 2024
Medical HAL Lower Limb Type (HAL-ML)
K233695
Cyberdyne, Inc.
Neurology · 172d
Cleared Dec 13, 2023
Atalante X
K232077
Wandercraft SAS
Neurology · 153d
Cleared Mar 02, 2023
ReWalk P6.0
K221696
Re Walk Robotics , Ltd.
Neurology · 265d
Cleared Dec 29, 2022
Atalante
K221859
Wandercraft SAS
Neurology · 185d
Cleared Jun 09, 2022
EksoNR
K220988
Ekso Bionics, Inc.
Neurology · 66d
Cleared Apr 21, 2022
GEMS-H
K213452
Samsung Electronics Co., Ltd.
Neurology · 177d
Cleared Jul 16, 2021
ExoAtlet-II
K201473
Exoatlet Asia Co. , Ltd.
Neurology · 408d
Cleared Oct 02, 2020
HAL for Medical Use(Lower Limb type)
K201559
Cyberdyne, Inc.
Neurology · 114d
Cleared Sep 09, 2020
Keeogo Dermoskeleton System
K201539
B-Temia, Inc.
Neurology · 92d
Cleared Jun 19, 2020
EksoNR
K200574
Ekso Bionics, Inc.
Neurology · 106d
Cleared May 26, 2020
ReWalk P6.0
K200032
Re Walk Robotics , Ltd.
Neurology · 140d
Cleared Jun 03, 2019
ReWalk Restore
K190337
Re Walk Robotics , Ltd.
Neurology · 109d
Cleared Apr 17, 2019
Phoenix
K183152
Us Bionics, Inc. (Dba Suitx)
Physical Medicine · 154d
Cleared Dec 14, 2018
Honda Walking Assist Device
K181294
Honda Motor Company, Ltd.
Neurology · 212d
Cleared Jan 31, 2018
Indego(R)
K173530
Parker Hannifin Corporation
Neurology · 77d
Cleared Dec 17, 2017
HAL for Medical Use (Lower Limb Type)
K171909
Cyberdyne, Inc.
Neurology · 174d
Cleared Sep 08, 2017
Indego
K171334
Parker Hannifin Corporation
Neurology · 123d
Cleared Jul 22, 2016
ReWalk(TM)
K160987
Rewalk Robotics, Inc.
Neurology · 105d
Cleared Jul 19, 2016
Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
K161443
Ekso Bionics, Inc.
Neurology · 55d
Cleared Apr 01, 2016
Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
K143690
Ekso Bionics, Inc.
Neurology · 464d
Cleared Feb 26, 2016
Indego
K152416
Parker Hannifin Corporation
Neurology · 184d

About Product Code PHL - Regulatory Context

510(k) Submission Activity

25 total 510(k) submissions under product code PHL since 2014, with 24 receiving FDA clearance (average review time: 182 days).

Submission volume has declined in recent years - 3 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 217 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 →