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510(k) Data Aggregation

    K Number
    K092589
    Device Name
    THERMOTEX PLATINUM SYSTEM
    Manufacturer
    EAS CONSULTING GROUP LLC
    Date Cleared
    2010-01-28

    (157 days)

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

    EAS CONSULTING GROUP LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thermotex Heat Therapy Systems are indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains and minor muscular back pain; muscular relaxation; and the temporary increase of local circulation where applied.
    Device Description
    The Thermotex Heat Therapy Systems provide infrared heat to different areas of the patient's body. The Systems consist of an outer application cover with adjustable pads that enclose the infrared heating elements to treat different areas of the body. The pad's covers are fabricated of nylon-cotton blend. Velcro fasteners on the cover allow for adjusting the cover and pads for optimum contact to the patient's body areas.
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