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 Parker Hannifin Corporation.

26
Total
25
Cleared
185d
Avg days
2014
Since
Stable submission activity - 4 submissions in the last 2 years
Review times increasing: avg 226d recently vs 178d historically

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

26 devices
1–24 of 26
Cleared Sep 02, 2026
Trexo Theo
K254198
Trexo Robotics, Inc.
Neurology · 253d
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

About Product Code PHL - Regulatory Context

510(k) Submission Activity

26 total 510(k) submissions under product code PHL since 2014, with 25 receiving FDA clearance (average review time: 185 days).

Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.

FDA 510(k) Review Time - PHL Product Code

Recent submissions under PHL have taken an average of 226 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 →