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FDA 510(k) Applications for Medical Device Product Code "PHL"
FDA 510(k) Number
Applicant
Device Name
Decision Date
DEN130034
ARGO MEDICAL TECHNOLOGIES, INC.
REWALK
06/26/2014
K201539
B-Temia Inc.
Keeogo Dermoskeleton System
09/09/2020
K171909
CYBERDYNE Inc.
HAL for Medical Use (Lower Limb Type)
12/17/2017
K201559
Cyberdyne Inc.
HAL for Medical Use(Lower Limb type)
10/02/2020
K200574
Ekso Bionics, Inc.
EksoNR
06/19/2020
K220988
Ekso Bionics, Inc.
EksoNR
06/09/2022
K143690
EKSO BIONICS, INC.
EksoÖ (version 1.1) and Ekso GTÖ (version 1.2)
04/01/2016
K161443
EKSO BIONICS, INC.
EksoÖ (version 1.1) and Ekso GTÖ (version 1.2)
07/19/2016
K201473
ExoAtlet Asia Co. Ltd.
ExoAtlet-II
07/16/2021
K181294
Honda Motor Company, Ltd.
Honda Walking Assist Device
12/14/2018
K152416
PARKER HANNIFIN CORPORATION
Indego
02/26/2016
K171334
Parker Hannifin Corporation
Indego
09/08/2017
K173530
Parker-Hannifin Corporation
Indego(R)
01/31/2018
K160987
REWALK ROBOTICS INC.
ReWalk(TM)
07/22/2016
K221696
ReWalk Robotics Ltd.
ReWalk P6.0
03/02/2023
K200032
ReWalk Robotics Ltd.
ReWalk P6.0
05/26/2020
K190337
ReWalk Robotics Ltd.
ReWalk Restore
06/03/2019
K213452
Samsung Electronics Co., Ltd.
GEMS-H
04/21/2022
K183152
US Bionics, Inc. (DBA suitX)
Phoenix
04/17/2019
K221859
Wandercraft SAS
Atalante
12/29/2022
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