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510(k) Data Aggregation

    K Number
    K011768
    Device Name
    THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202
    Manufacturer
    THERMO-ELECTRIC CO.
    Date Cleared
    2001-08-03

    (57 days)

    Product Code
    LSB
    Regulation Number
    890.5100
    Why did this record match?
    Product Code :

    LSB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Increase of Local Blood Circulation. Treatment of Range of Motion when combined with exercise. Treatment for minor pain and stiffness of non-rheumatoid arthritis.
    Device Description
    The Fluidotherapy type devices describe a process where ground cellulose is held in animated suspension through a screen filter (often called the Fluidizing Bed) and held captive by a housing and flexible velcro tightening sleeves. This process then allows for a hand, wrist, foot, ankle, and on larger units, the lower leg to be immersed in the heated cellulose. The now fluidized cellulose gently and warmly massages the extremity resulting in improved blood circulation, wound healing, comfort, etc. Thermo-Electric's Thermo-Therapy devices have identical technology characteristics to that of Fluidotherapy.
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    K Number
    K011243
    Device Name
    CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000
    Manufacturer
    CHATTANOOGA GROUP, INC.
    Date Cleared
    2001-07-06

    (74 days)

    Product Code
    LSB
    Regulation Number
    890.5100
    Why did this record match?
    Product Code :

    LSB

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