510(k) Report

Devices descending from DEN130034

20 later devices reach Rewalk through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171909HAL for Medical Use (Lower Limb Type)Cyberdyne, Inc.20173—
+1K143690Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc.201614—
+1K152416IndegoParker Hannifin Corporation20167—
+2K201473ExoAtlet-IIExoatlet Asia Co., Ltd.20210—
+2K201559HAL for Medical Use (Lower Limb type)Cyberdyne, Inc.20202—
+2K173530Indego (R)Parker-Hannifin Corporation20185—
+2K171334IndegoParker Hannifin Corporation20176—
+2K161443Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc.201612—
+3K260381EveWandercraft SAS20260—
+3K233695Medical HAL Lower Limb Type (HAL-ML)Cyberdyne, Inc.20241—
+3K232077Atalante XWandercraft SAS20232—
+3K221859AtalanteWandercraft SAS202231
+3K200574EksoNREkso Bionics, Inc.20201—
+3K190337ReWalk RestoreRe Walk Robotics, Ltd.20190—
+3K181294Honda Walking Assist DeviceHonda Motor Company, Ltd.20182—
+4K254198Trexo TheoTrexo Robotics, Inc.20260—
+4K250904Atalante XWandercraft SAS20251—
+4K220988EksoNREkso Bionics, Inc.20220—
+4K213452GEMS-HSamsung Electronics Co., Ltd.20220—
+4K201539Keeogo Dermoskeleton SystemB-Temia, Inc.20200—