Atalante X

GUDID 03665965000129

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.

WANDERCRAFT

Programmable ambulation exoskeleton, clinical

• Primary Device ID: 03665965000129
• NIH Device Record Key: 420be3be-8b55-4875-9472-de7af16771ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atalante X
• Version Model Number: DMR-ATA-002.2
• Company DUNS: 264523488
• Company Name: WANDERCRAFT
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03665965000129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221859

FDA Product Code

• PHL: Powered Exoskeleton

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-21
• Device Publish Date: 2023-03-13