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510(k) Data Aggregation

    K Number
    DEN130034
    Device Name
    REWALK
    Manufacturer
    ARGO MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2014-06-26

    (374 days)

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

    ARGO MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ARGO ReWalk™ orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions with supervision of a specially trained companion in accordance with the user assessment and training certification program. The device is also intended to enable individuals with spinal cord injury at levels T4 to T6 to perform ambulatory functions in rehabilitation institutions in accordance with the user assessment and training certification program. The ReWalk™ is not intended for sports or stair climbing.
    Device Description
    The device is a wearable exoskeleton device (refer to Figure 2 below) that allows the user to enable ambulation over the course of the day (refer to Figure 1 below). The control of the device is achieved through a wrist-worn user-operated wireless communicator, tilt sensor and specific body movements. The movement of the swing leg is controlled by a set of gears and DC motors at the knee and hip joints.
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