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    K Number
    K093100
    Device Name
    REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA)
    Manufacturer
    SHENZHEN COMFORT TECHNOLOGY CO., LTD.
    Date Cleared
    2009-11-24

    (54 days)

    Product Code
    IMC
    Regulation Number
    890.5110
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHENZHEN COMFORT TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Revlon RVSP3501 (Type SPB3752EA) Spa MoistureStay Paraffin Bath is: - Useful in symptomatic relief of pain caused by arthritis, bursitis, and chronic joint inflammation. - Relaxes muscles, relieves stiffness and muscle spasm - Stimulates circulation and for other conditions where heat is indicated.
    Device Description
    The Revlon RVSP3501 (Type SPB3752EA) Spa MoistureStay Paraffin Bath is an 80 Watt paraffin bath unit, with a thermostat that varies the heat from High to Keep Warm. There are two LEDs, a red LED for the heater, and a green LED to indicate the power. The unit is provided with 3lbs of paraffin wax, a plastic mat when dipping the hands or feet, glove liners, and a pair of mitts.
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