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510(k) Data Aggregation

    K Number
    K060043
    Device Name
    KHAN KINETIC TREATMENT DEVICE (KKT-M1)
    Manufacturer
    OPTIMA HEALTH SOLUTIONS INTERNATIONAL, INC.
    Date Cleared
    2006-03-23

    (76 days)

    Product Code
    LXM
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPTIMA HEALTH SOLUTIONS INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KKT device is to be used in the aid of management of chronic pain due to non-congenital defects. The KKT device is to be used as part of a series of steps in the total care of the patient. The device is to be used for the treatment of vertebral motor units which appear to be fixated. The procedure can involve xray analysis that quantifies the lateral and rotational misalignments between the vertebrae. The treatment is then administered using the KKT device to deliver precise impulses at a required vector configuration.
    Device Description
    The KKT device provides an integrated treatment system unlike manual manipulation of the upper cervical spine, applying significantly smaller forces than those applied manually. While other handheld devices have been used which employ similar treatment methods, the KKT device provides significant advancement and improvement in moments, the ANT repeatability. The device consists of a display and controller, a force application probe, and a multi-axis adjustable stand. The device is used to apply force, rotation, and vibration to a patient.
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