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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