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510(k) Data Aggregation

    K Number
    K072064
    Device Name
    GRAVILAX TRACTION SYSTEM
    Manufacturer
    THERAPEUTIC CLINICAL TECHNOLOGIES, INC.
    Date Cleared
    2008-04-21

    (269 days)

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

    THERAPEUTIC CLINICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GraviLax Traction System is intended for use in exerting therapeutic pulling forces on the patient's body. The device utilizes a cylindrical hot tub in which the patient is suspended vertically by a shoulder harness and which contains salt water whose salinity is adjusted to a specific gravity of approximately 1.2 providing an increased natural buoyancy to the user's body. Decompressive force (unloading due to distraction and positioning) to the sacral, lumbar and thoracic spine is achieved by application of suitable weights to the patient's ankles This device is for prescription use only and is limited to use by qualified personnel in a suitably equipped treatment facility.
    Device Description
    The device is a powered traction device pursuant to 21 CFR 890.5900 (FDA product code ITH) class 2. The device is substantially equivalent to various other traction devices which achieve their effect through the force of gravity and/or mechanical means.
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    K Number
    K010680
    Device Name
    CT SPACER
    Manufacturer
    CLINICAL TECHNOLOGIES, INC.
    Date Cleared
    2001-05-23

    (77 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLINICAL TECHNOLOGIES, INC.

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