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510(k) Data Aggregation

    K Number
    K162702
    Device Name
    Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table
    Manufacturer
    STL International, Inc.
    Date Cleared
    2016-12-30

    (93 days)

    Product Code
    HST
    Regulation Number
    888.5850
    Why did this record match?
    Product Code :

    HST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Teeter Decompression Devices are multiple user, reusable devices for home use, intended to provide traction to the spine while stretching the para-spinal muscles and soft tissues. The devices provide non-powered traction and are meant for use by adults. Use of the Teeter Decompression Devices is indicated for the following conditions: back pain, muscle tension, degenerative disc disease, spinal degenerative joint disease, spinal stenosis, herniated disc, spinal curvature due to tight muscles, sciatica, muscle spasm, and facet syndrome.
    Device Description
    Teeter's decompression devices are designed to decompress the spine and stretch paraspinal soft tissues. The devices are non-powered, external (non-invasive) and usercontrolled. Decompression is accomplished in various ways depending on the model within the Teeter product family.
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    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?
    Product Code :

    HST

    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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    K Number
    K984190
    Device Name
    BACK-ON-TRAC, MODEL 101BOT
    Manufacturer
    BACK-ON-TRACK, INC.
    Date Cleared
    1999-03-15

    (112 days)

    Product Code
    HST, FEB
    Regulation Number
    888.5850
    Why did this record match?
    Product Code :

    HST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BACK - ON - TRAC is intended for the treatment of acute and chronic low back pain of disc origin or due to malalignments of the apophyseal joints.
    Device Description
    Not Found
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