Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K053503
    Device Name
    VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE)
    Manufacturer
    VAX-D MEDICAL TECHNOLOGIES USA, L.C.
    Date Cleared
    2005-12-28

    (12 days)

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

    VAX-D MEDICAL TECHNOLOGIES USA, L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This therapy provides a primary treatment modality for the management of pain and disability for patients suffering with low back pain. It has been found to provide relief in a variety of conditions involving anatomical dysfunctions of the lumbar spine that generate localized low back pain as well as peripheral radiation, including patients with protruding or herniated intervertebral discs as well as those with acute facet problems and sciatica. This therapy provides a primary treatment modality for the management of pain and disability for patients suffering with compressive and degenerative injuries of the spine. It has been found to provide relief of pain and symptoms associated with herniated discs, bulging discs, degenerative disc disease, posterior facet syndrome, and sciatica.
    Device Description
    The VAX-D Genesis System is designed to apply distraction tensions to the patient's lumbar spine in order to non-surgically decompress the intervertebral discs. The patient's upper body is positioned on the stationary portion of the table and is restrained by the patient holding on to adjustable handgrips, or by the use of a passive shoulder restraint. The table is a split table design, whereby distraction tensions are applied to the patient first by a pelvic harness attached to a tensionometer and by the separation of the moveable part of the table. The system is designed to apply tensions to the lumbar spine in a patented logarithmic time/force curve that allows trunk and paraspinal muscles to relax. The system is managed on variable timed distraction-relaxation cycles. For safety the patient holds on to handgrips which can be released at any time to end the session and restore full relaxation. The patient may choose to use a passive shoulder restraint that utilizes a patient 'quick release' buckle, or they may simply raise their arms to release. Distraction tensions and rates are continuously monitored and measured by the tensionometer in the pelvic belt, and adjusts the tension to produce a patented logarithmic decompression curve. The chart recording produced is a permanent record of the treatment parameters which becomes part of the patient's chart.
    Ask a Question

    Page 1 of 1