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510(k) Data Aggregation

    K Number
    K023161
    Device Name
    SMARTSTEP SYSTEM
    Manufacturer
    ANDANTE MEDICAL DEVICE, LTD.
    Date Cleared
    2002-12-10

    (78 days)

    Product Code
    IRN
    Regulation Number
    890.5575
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANDANTE MEDICAL DEVICE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmartStep System is intended to sense the amount of weight applied to the plantar surface of the foot during rehabilitation. The device alerts the user and/or therapist with alarm when the weight exceeded the pre-selected value. Furthermore, the SmartStep System is intended to be used in any situation in which therapist and/or patient would benefit from objectively assessing the amount of weight that is being applied to a lower limb.
    Device Description
    The SmartStep System is a biofeedback system for gait training and reeducation. The device is a tool to assist clinicians accurately assess patients who are undergoing weight bearing restrictions and gait therapy training. The SmartStep is used to measure the amount of weight being applied to an affected limb, to teach and promote specific weight bearing skills, and to test patient's ability to maintain a weight bearing rang. A patient's weight bearing status is important to know because it is an indicator of overall progress, and with certain conditions, under-weight bearing or over-weight bearing can lead to complication in the rehabilitation process. The SmartStep system is to be used under the supervision of physician or licensed health care provider such as physiotherapist. The SmartStep system is comprised of three sub elements: Flexible Foot force insole that is placed on the inside of a shoe worn by the patient over a sock. Central Processing Unit (CPU)- the unit is connected to computer software. Computer software that acts as a patient medical record and patient assessment tool.
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