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510(k) Data Aggregation

    K Number
    K063568
    Device Name
    HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL
    Date Cleared
    2007-03-22

    (114 days)

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

    SUZHOU MEDICAL APPLIANCE FACTORY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HWATO TDP Heat Lamp, including TDP11-DL, TDP12-XL, and TDP-22XL, is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help to relieve minor pain associated with muscle spasms, minor sprains and strains, and minor muscular back pain.
    Device Description
    Not Found
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