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510(k) Data Aggregation

    K Number
    K250904
    Device Name
    Atalante X
    Manufacturer
    Wandercraft SAS
    Date Cleared
    2025-10-24

    (212 days)

    Product Code
    PHL
    Regulation Number
    890.3480
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K220988,K232077
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K220988

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Atalante X is intended to perform ambulatory functions and mobility exercises, hands‐free, in rehabilitation institutions under the supervision of a trained operator for the following populations:

    • Individuals with hemiplegia due to cerebrovascular accident (CVA)
    • Individuals with spinal cord injuries at levels C4 to L5 (SCI)
    • Individuals with multiple sclerosis (MS)

    The operator must complete a training program prior to use of the device.

    Atalante X is intended to be used on adolescents of 18 years and older and adults, able to tolerate a stand‐up position.

    The device is not intended for sports or stair climbing.

    Device Description

    Atalante X 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.

    AI/ML Overview

    N/A

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