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510(k) Data Aggregation

    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?
    Product Code :

    IMC

    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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    K Number
    K022626
    Device Name
    MOISTURESTAY (REVLON)
    Manufacturer
    RAYMOND INDUSTRIAL, LTD.
    Date Cleared
    2002-10-29

    (83 days)

    Product Code
    IMC
    Regulation Number
    890.5110
    Why did this record match?
    Product Code :

    IMC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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
    Luxury Paraffin Bath
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    K Number
    K013707
    Device Name
    SOFTIQUE, MODEL GI 11001
    Manufacturer
    GLOBAL TV CONCEPTS, LTD.
    Date Cleared
    2002-02-01

    (85 days)

    Product Code
    IMC
    Regulation Number
    890.5110
    Why did this record match?
    Product Code :

    IMC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Softique™ Paraffin Bath is an over-the-counter device intended for the following uses: 1. Useful in symptomatic relief of pain caused by arthritis, bursitis, and chronic joint inflammation 2. Relaxes muscles, relieves stiffness and muscle spasm 3. Stimulates circulation and for other conditions where heat is indicated
    Device Description
    The Softique™ Paraffin Bath is a full-size paraffin bath with a paraffin wax capacity of five pounds (with a recommended use of three to four pounds of paratin wax), a melting time for the paraffin wax of approximately five hours, and a temperature range for the paraffin wax of 123-130°F. The unit utilizes two heaters with a total of 90 W in order to melt and maintain the temperature of the melted paraffin wax. The unit has an operation voltage of 120 V, 60 Hz. The Softique™ Paraffin Bath is supplied with a power cord, a plastic lid, three pounds of pure, hypo-allergenic paraffin wax, and 60 plastic liners.
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    K Number
    K013328
    Device Name
    REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600
    Manufacturer
    REMINGTON PRODUCTS COMPANY, L.L.C.
    Date Cleared
    2001-12-03

    (59 days)

    Product Code
    IMC
    Regulation Number
    890.5110
    Why did this record match?
    Product Code :

    IMC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Useful for 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 product covered by this 510(k) summary is a heated paraffin wax spa intended for home use. This product consists of a plastic enclosure, aluminum bucket and an internal heating assembly. The paraffin wax temperature is controlled by a variable electronic heat control with timing circuit. Temperature settings (low, medium, and high) and timing controls are displayed on a liquid crystal display. The product consumes 200 watts when plugged into a standard household electrical outlet supply of 120 Vac, 60 Hertz. The product comes in two different sizes.
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    K Number
    K001860
    Device Name
    PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA
    Manufacturer
    HOMEDICS, INC.
    Date Cleared
    2000-08-10

    (52 days)

    Product Code
    IMC
    Regulation Number
    890.5110
    Why did this record match?
    Product Code :

    IMC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991427
    Device Name
    PARAMED PARAFFIN WARMER
    Manufacturer
    DIVI INTL. CO.
    Date Cleared
    1999-08-13

    (112 days)

    Product Code
    IMC
    Regulation Number
    890.5110
    Why did this record match?
    Product Code :

    IMC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in temporary symptomatic relief of minor pain due to medically diagnosed arthritis and bursitis. Relaxes muscles, aids in the relief of stiff muscles, muscle spasms; helps to stimulate circulation.
    Device Description
    Paramed Paraffin Warmer
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    K Number
    K980718
    Device Name
    PARA-CARE
    Manufacturer
    CHATTANOOGA GROUP, INC.
    Date Cleared
    1998-03-27

    (31 days)

    Product Code
    IMC
    Regulation Number
    890.5110
    Why did this record match?
    Product Code :

    IMC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Useful in symptomatic relief of pain caused by medically diagnosed 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
    Not Found
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