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510(k) Data Aggregation

    K Number
    K232077
    Device Name
    Atalante X
    Manufacturer
    Wandercraft SAS
    Date Cleared
    2023-12-13

    (153 days)

    Product Code
    PHL
    Regulation Number
    890.3480
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wandercraft SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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 T5 to L5 (SCI). 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 selfbalancing and includes dynamic-walking control. Dynamic-walking allows the Atalante X to consume significantly less power and have a more natural gait.
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    K Number
    K221859
    Device Name
    Atalante
    Manufacturer
    Wandercraft SAS
    Date Cleared
    2022-12-29

    (185 days)

    Product Code
    PHL
    Regulation Number
    890.3480
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wandercraft SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atalante exoskeleton is intended to enable individuals with hemiplegia due to cerebrovascular accident (CVA) to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation under the supervision of a trained operator. The operator must complete a training program prior to use of the device. The Atalante system 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
    The Atalante 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 is self-balancing and includes dynamic-walking control. Dynamic-walking allows the Atalante to consume significantly less power and have a more natural gait.
    Ask a Question

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