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510(k) Data Aggregation

    K Number
    K033035
    Device Name
    TLC MODELS ULK-H AND ULT-H INFRARED LAMPS
    Manufacturer
    TLC MARKETING, INC.
    Date Cleared
    2003-11-20

    (52 days)

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

    TLC MARKETING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used 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, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
    Device Description
    The ULK-H and ULT-H lamps each contain a number of quartz bulbs with ceramic coatings that when heated emits infrared radiation with wavelengths from 8 to 40 microns (8.000 to 40.000 nanometers).
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