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510(k) Data Aggregation

    K Number
    K111273
    Device Name
    FIR HEAT THERAPHY SYSYEMS
    Manufacturer
    SHENZHEN ANPAN TECHNOLOGY CO., LTD.
    Date Cleared
    2011-11-08

    (188 days)

    Product Code
    IRT, ILY
    Regulation Number
    890.5740
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHENZHEN ANPAN TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FIR 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 FIR 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 nyloncotton 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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