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510(k) Data Aggregation

    K Number
    K981822
    Device Name
    DRS SYSTEM
    Manufacturer
    PROFESSIONAL DISTRIBUTION SYSTEMS, INC.
    Date Cleared
    1998-06-24

    (33 days)

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

    PROFESSIONAL DISTRIBUTION SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DRS System provides a program of treatments for relief from pain for those patients suffering with low back pain. Each treatment consists of a physician prescribed treatment period on the DRS System 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 herniated discs, protruding 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.
    Device Description
    The DRS System™ is designed to apply distraction forces to a patient's lumbar spine. The key elements are as follows: 1. The bed is a stand on/stand off tilt type bed that allows the fully clothed patient to stand on the bed in the vertical position. The bed and patient can then be slowly lowered to the horizontal treatment position using a remote controller hand held by the practitioner. 2. Once in the horizontal position the bed can be raised or lowered to the practitioner's preferred treatment height via the same hand held remote controller. 3. The bed is split into two cushions, each slideable in the horizontal plane only on low friction runners and each being able to be locked independently. 4. Distraction tensions are applied to the patient via a pelvic harness while the upper body of the patient is anchored to the locked upper (cephalic) cushion via a chest harness and adjustable underarm supports. The lower cushion, which is unlocked and on which the patient's lower trunk is rested, is able to slide easily thus reducing almost completely any frictional movement between patient and bed cushion when distraction tensions are applied, this concentrates virtually all the forces to the affected part of the lumbar spine. 5. The distraction unit (Vertrac) is mounted to a vertical movable platform incorporated into a support tower (Omni Tower) at the foot end of the bed. This enables the distraction tensions to be applied at differing angles to the patient (between 0 and 30 degrees). 6. The "Vertrac" unit is programmed and control panel fitted into the "Omni Tower" to give static or intermittent distraction. 7. The minimum and maximum distraction settings are 0-200 lbs. 8. Treatment parameters i.e. tensions and time are continuously monitored and shown by LCD readout at the time of treatment set up and during treatment. 9. At the conclusion of treatment time, tension always returns to zero. 10. A cassette player, which is incorporated in a separate section of the control panel, and wireless headphones together with an overhead fluorescent "black light" provide comfort and relaxation to the patient. 11. There is instantaneous release of all tensions if the patient pushes the button on the hand held Patient Safety Switch, or the Stop Button on the control panel has been pushed by the practitioner. 12. The DRS System™ will not operate if the Patient Safety Switch is not working properly or has not been tested prior to each treatment. 13. The treatment cannot be restarted when a patient activates the Patient Safety Switch or the Stop Button has been pushed during treatment unless all treatment parameters are manually re-entered into the controller.
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