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510(k) Data Aggregation

    K Number
    K140865
    Device Name
    INFRARED HEATING DEVICE
    Date Cleared
    2014-09-03

    (153 days)

    Product Code
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRO MEDICAL SUPPLIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Infrared Heating Device, Model PM-750, temporarily increases local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains.
    Device Description
    The Infrared Heating Device, Model PM-750, is 110V AC powered, non-invasive, therapeutic medical device that provides continuous heat therapy through the use of infrared bulb. The device consists of a handle that houses the electronics and controls, and tungsten infrared bulb with light filter. The light filter is intended to be placed directly on the skin to provide topical heating. The infrared bulb is replaceable. The housing material is ABS.
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