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510(k) Data Aggregation

    K Number
    K102281
    Device Name
    THERMAL MASSAGE BED, MODEL 2D-GX
    Manufacturer
    Date Cleared
    2010-12-22

    (133 days)

    Product Code
    Regulation Number
    890.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    INAREX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Thermal Massage Bed (2D-GX) is a device intended to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the lamps provide topical heating. -temporary relief of minor muscle and joint pain, and stiffness -temporary relief of minor joint pain associated with arthritis -temporary increase in local circulation where applied -Relaxation of muscles
    Device Description
    This device is intended to provide patient with muscle relaxation therapy by delivering heat and soothing massage. This device has auto mode, and four custom modes to massage the back and apply heat to calves and thighs. For the upper mattress, there are germanium ceramic roller controlled left and right by motor. Germanium ceramic roller also can be controlled up and down. The users can choose the auto mode or custom mode by using the remote control and the remote control has the FND screen which shows the temperature and LED which indicates operation condition.
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    K Number
    K080554
    Device Name
    INAREX, MODEL 2D-LX
    Manufacturer
    Date Cleared
    2008-08-27

    (181 days)

    Product Code
    Regulation Number
    890.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    INAREX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Thermal Massage Bed (2D-LX) is a device intended to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the infrared lamps provide topical heating for; - temporary relief of minor muscle and joint pain, and stiffness - temporary relief of minor joint pain associated with arthritis - temporary increase in local circulation where applied - Relaxation of muscles
    Device Description
    Thermal Massage Bed (2D-LX) is a device intended to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the infrared lamps provide topical heating for; - temporary relief of minor muscle and joint pain, and stiffness - temporary relief of minor joint pain associated with arthritis - temporary increase in local circulation where applied - Relaxation of muscles
    Ask a Question

    Ask a specific question about this device

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