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510(k) Data Aggregation

    K Number
    K070672
    Device Name
    MASSAGE MATTRESS VM9100RM
    Manufacturer
    Date Cleared
    2007-06-26

    (106 days)

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

    METEK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended: To provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the radiant infrared heat provides topical heating for: the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of minor joint pain associated with arthritis; the temporary increase in local circulation where applied; muscle relaxation. The device is easy and safe to use and can therefore be used in hospitals as well as at home and in gymnasiums. The MASSAGE BED VM9100R as been produced for over-the-counter use.
    Device Description
    The MASSAGE MATTRESS VM9100RM is an electrically powered motorized multi-functional physical therapy mattress. It is intended to provide muscle relaxation therapy by delivering heat and soothing massage. The massage function is delivered by oscillating motors that are embedded in the mattress body. The heat function is delivered by two components (1) a back pad and (2) a calf pad both containing a heating panel. In both cases, radiant infrared heat is emitted. Both, the oscillating function and the heated pressure apply light pressure as well as radiate infrared heat to the user.
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