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510(k) Data Aggregation

    K Number
    K130249
    Device Name
    INTEGRITY SPINAL CARE SYSTEM 3.0
    Manufacturer
    INTEGRITY LIFE SCIENCES
    Date Cleared
    2014-02-06

    (370 days)

    Product Code
    ITH, INT
    Regulation Number
    890.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRITY LIFE SCIENCES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Integrity Spinal Care System 3.0 provides a primary treatment modality for the management of pain and disability for patients suffering with incapacitating low back pain and sciatica. It is designed to apply spinal decompressive forces to compressive and degenerative injuries of the spine. It has been found to provide relief of pain and symptoms associated with herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, posterior facet syndrome, and sciatica.
    Device Description
    The Integrity Spinal Care System 3.0 incorporates the same principles and working characteristics of the predicate devices, the DRX9000 True Non Surgical Decompression System (K060735) and is same in size, shape and function. The components of The Integrity Spinal Care System 3.0 are substantially equivalent in form, fit, function and configuration to its predicate device the DRX9000 True Non Surgical Decompression System (K060735).There are similar key design technical characteristics; multi-function table designed to applied distraction forces and controlled by a computer console, same/similar components for treatment and measurement; similar size, power source, and performance.
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