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510(k) Data Aggregation

    K Number
    K140592
    Device Name
    CERAGEM AUTOMATIC THERMAL MASSAGER
    Manufacturer
    Ceragem International Inc.
    Date Cleared
    2014-12-17

    (285 days)

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

    Ceragem International Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Ceragem® Thermal Massager Model CGM-MB-1101 Automatic Thermal Massager is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for: - Temporary relief of minor muscle and joint pain 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 comprised of the main body and optional components. The main body components are the main mat which includes the internal projector and the up/down movement motor, and the lower mat. The optional components are the external projectors (3-sphere). This device is an electrically powered, motorized, multi-functional physical therapy table intended to use for temporary relief of muscle and joint pain and stiffness by applying massage pressure from the vertical and horizontal movements, and heat from the internal and external projectors.
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