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510(k) Data Aggregation

    K Number
    K110858
    Device Name
    LO-BAK TRAX
    Manufacturer
    ROLAND F BERTHIAUME, DC
    Date Cleared
    2011-08-02

    (127 days)

    Product Code
    HST
    Regulation Number
    888.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROLAND F BERTHIAUME, DC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lo-Bak TRAX is intended for single person use by adults to provide portable, nonpowered traction force to the lumbar spine and to stretch and relax the para-spinal muscles and soft tissues. Use of Lo-Bak TRAX is indicated for the following conditions: low back pain, degenerative disc disease, spinal degenerative joint disease, spinal stenosis, herniated disc, spinal curvature due to tight muscles, sciatica and muscle spasm.
    Device Description
    Lo-Bak TRAX is a non-powered, portable spinal traction device which is designed to simplify spinal traction of the lumbar spine and stretch the para-spinal soft tissues. It is light-weight (weighs less than 5 pounds) and compact, yet very strong and durable. Much like bicycle handlebars, there is a right and left handle. Correspondingly, there is a right and left thigh contact. The two thigh contacts are designed to align with the inguinal/thigh crease formed where the upper-most thigh attaches to the trunk when the hips are flexed 90 degrees. It has foam handle grips and ¼" SCE foam leg contact pads which both, provide comfort and function to prevent slippage while using the device. It is powder-coated with high gloss paint to make clean up easy with a warm, soapy cloth or disinfective wipe. There are no moving parts and no assembly required. It is ready to use from the moment you take it out of the box. This device is designed to traction the lumbar spine by utilizing the upper thighs as the contact point and the bilateral upper extremities as the traction force source. The device will accomplish this by having the user lie in a supine posture with the lower extremities flexed at both the hips and knees bilaterally with the heels positioned as close as comfortable to the corresponding buttock area. This posture flattens the lumbar lordosis, creating more of a straight line force vector which results in unweighting of the discs and facet joints while simultaneously relaxing the surrounding para-spinal musculature. This posture makes the spine more amenable to distraction with less force required than a device which attempts to traction the lumbar spine with the lumbar lordosis maintained.
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