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510(k) Data Aggregation

    K Number
    K002390
    Device Name
    QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H
    Manufacturer
    LSI INTL., INC.
    Date Cleared
    2000-11-02

    (90 days)

    Product Code
    JFB
    Regulation Number
    890.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    LSI INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantum Intersegmental Roller Traction Table uses a roller mechanism and electric motors coupled with vibration and optional heat to release muscle tension and deliver soothing massage by the movement of the roller carriage back and forth from the cervical area to the lumbar area of the patient.
    Device Description
    The Quantum Intersegmental Roller Traction Table features three six inch wide, six inch diameter rollers which rotate in a clockwise or counter-clockwise direction while tracking up and down the back. The roller height can be adjusted to place varying degrees of pressure on the muscles of the back while the patient is lying in the supine position.
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    K Number
    K984021
    Device Name
    MS300
    Manufacturer
    LSI INTL., INC.
    Date Cleared
    1999-01-28

    (77 days)

    Product Code
    IPF, NOV
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    LSI INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Relaxation of muscle spasm. Prevention of retardation of disuse atrophy. Increasing local blood circulation. Muscle re-education. Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis. Maintaining or increasing range of motion.
    Device Description
    Not Found
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    K Number
    K984113
    Device Name
    MS400
    Manufacturer
    LSI INTL., INC.
    Date Cleared
    1999-01-28

    (72 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    LSI INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Relaxation of Muscle Spasm - Prevention of Retardation of disuse atrophy. - Increasing local blood circulation - Muscle Re-education. - Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis. - Maintaining or increasing range of motion.
    Device Description
    Not Found
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    K Number
    K970696
    Device Name
    S.P. 100
    Manufacturer
    LSI INTL., INC.
    Date Cleared
    1997-03-18

    (21 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    LSI INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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