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510(k) Data Aggregation

    K Number
    K160987
    Device Name
    ReWalk(TM)
    Manufacturer
    REWALK ROBOTICS INC.
    Date Cleared
    2016-07-22

    (105 days)

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

    REWALK ROBOTICS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 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 function 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 perform ambulatory functions in rehabilitations in accordance with the user assessment and training certification program. The ReWalk™ is not intended for sports or stair climbing.
    Device Description
    The ReWalk™ orthotically fits to the lower limbs and part of the upper body.
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