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510(k) Data Aggregation

    K Number
    K073132
    Device Name
    MODEL D DISC FORCE
    Manufacturer
    NORTH AMERICAN MEDICAL CORP (NAM)
    Date Cleared
    2008-04-03

    (148 days)

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

    NORTH AMERICAN MEDICAL CORP (NAM)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model D -- Disc Force provides a program of traction type treatments for relief from pain for patients suffering with low back pain and neck pain. Each treatment consists of a physician prescribed treatment period on the Model D - Disc Force and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back or neck pain. Conditions that may be treated include neck and back pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of inter-vertebral discs, that is, unloading due to distraction and positioning.
    Device Description
    The main parts of the Model D are as follow: 1. The bed is a stand on / stand off type of bed that can be tilted to allow the fully clothed patient to step onto a footrest while in the vertical position and then be slowly lowered to the horizontal treatment position using a remote control hand held by the practitioner. 2. The bed is split into two cushions which slide on low friction runners only in the horizontal plane and which can be locked independently. 3. Distraction tensions are applied to the patient via a pelvic harness while the upper torso is anchored to the locked cephalic cushion via a chest harness. The lower cushion, on which the lower torso of the patient rests, is unlocked and able to slide freely, thus negating any frictional movement between the patient and the bed cushions during the application of distraction forces and ensuring the efficiency of the application of the prescribed force. 4. The distraction unit is mounted to a vertical movable platform incorporated into a support tower at the foot end of the bed. This enables the distraction tensions to be applied at differing angles (ranging from 0 to 27 degrees) to the patient. 5. The distraction unit is programmable and controlled from a control panel fitted into the tower to provide static or intermittent distraction. 6. The minimum and maximum distraction settings are 0 200 pounds. 7. Treatment parameters, such as time and tension, are continuously monitored and displayed by the control panel during set up and during treatment. 8. At the conclusion of the duration of the treatment session, the tension always returns to zero. 9. A flat panel monitor, which is incorporated in a separate section of the control tower, with headphones provides comfort and relaxation to the patient and / or educational opportunities. 10. The system incorporates a Patient Interrupt Switch; an Emergency Interrupt Switch; and a Power Switch, which, when selected independently, in tandem, or in unison, results in the immediate release of all tension. 11. The Model D will not operate if the Patient Switch is not working properly or has not been tested prior to the commencement of each treatment session. 12. If the Patient Interrupt Switch, or the Emergency Interrupt Switch is activated during a session, or power is interrupted, all treatment parameters must be manually re-entered before the treatment session will restart.
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    K Number
    K033231
    Device Name
    SPINA SYSTEM
    Manufacturer
    NORTH AMERICAN MEDICAL CORP (NAM)
    Date Cleared
    2005-09-09

    (704 days)

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

    NORTH AMERICAN MEDICAL CORP (NAM)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device provides a program of treatments for relief from pain and disability for those patients suffering with low back pain. A treatment will consist of a physician prescribed treatment period on the device and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with hemiated discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning. The SPINA SYSTEM CERVICAL also offers a cervical accessory which provides a program of treatments for relief from neck pain associated with herniated discs, degenerative disc disease, and posterior facet syndrome. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
    Device Description
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