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510(k) K250904

Device
Atalante X
Applicant
Wandercraft SAS
510(k) number
K250904
Product code
PHL
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-24
Date received
2025-03-26
Regulation
890.3480
Classification name
Powered Exoskeleton
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Mélanie Combes
Address
88 Rue De Rivoli Paris FR 75004 75004

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K201473ExoAtlet-IIExoatlet Asia Co. , Ltd.2021-07-16
K201559HAL for Medical Use(Lower Limb type)Cyberdyne, Inc.2020-10-02
K201539Keeogo Dermoskeleton SystemB-Temia, Inc.2020-09-09
K200574EksoNREkso Bionics, Inc.2020-06-19
K200032ReWalk P6.0Re Walk Robotics , Ltd.2020-05-26
K190337ReWalk RestoreRe Walk Robotics , Ltd.2019-06-03
K183152PhoenixUs Bionics, Inc. (Dba Suitx)2019-04-17
K181294Honda Walking Assist DeviceHonda Motor Company, Ltd.2018-12-14