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510(k) Data Aggregation

    K Number
    K062635
    Device Name
    MODEL 2200
    Manufacturer
    CLARIMEDEX, INC.
    Date Cleared
    2006-12-19

    (104 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLARIMEDEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CLARIMEDIX device is indicated for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase blood circulation where applied.
    Device Description
    The system is a self-contained unit with four treatment areas. - . Popliteal treatment zone - Calf treatment zone . - Foot treatment zone . - . Heel treatment zone
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