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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?
    Applicant Name (Manufacturer) :

    STL International, Inc.

    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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