Device
The Atalante X by Wandercraft is a completely self-balancing walking system for people with mobility disabilities. It is a fully powered hip-knee-ankle lower body exoskeleton with...
Manufacturer
WANDERCRAFT
WANDERCRAFT
Model: ATA-2.5.1-EN US
DI: 03665965000167
Status: New
MRI: MR Unsafe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Description
The Atalante X by Wandercraft is a completely self-balancing walking system for people with mobility disabilities. It is a fully powered hip-knee-ankle lower body exoskeleton with 12 actuated degrees of freedom. Atalante X is self-balancing and includes dynamic-walking control. Dynamic walking allows the Atalante X to consume significantly less power and have a more natural gait. The Atalante X is a tool for physical therapy.
It is meant to be highly adjustable and be applicable for various stages of physical rehabilitation, re-mobilization and exercises.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b03784f6-c7a3-4ef2-8098-61eaa16e00fb
Distribution Status:
In Commercial Distribution
DUNS Number:
264523488
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
03665965000167
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 58943
Name: Programmable ambulation exoskeleton, clinical
Definition:
A battery-powered, pre-programmed, lower-limb orthosis system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function by manipulating the legs through a normal walking pattern during ambulation. The system includes an exoskeleton structure made of metal with electric motors, mechanical actuators, and sensors for feedback; it is typically strapped to the legs over clothing. It is intended for multiple-patient use, in a controlled clinical setting (e.g., gait lab, rehabilitation centre) under healthcare professional supervision.
FDA Product Codes
PHL
Powered Exoskeleton
Premarket Submissions
Submission Number:
K250904
Supplement Number:
000