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510(k) Data Aggregation

    K Number
    K120254
    Device Name
    THERASAGE HEATING PAD
    Date Cleared
    2012-03-06

    (39 days)

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

    THERASAGE CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Therasage™ Heating Pad is intended to provide topical heating to the user indicated for (a) the temporary relief of minor muscle and joint pain and stiffness: (b) the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains, and sprains, and minor muscular back pain; (c) muscular relaxation; and (d) the temporary increase of local circulation where applied.
    Device Description
    The Therasage™ Heating Pad provides infrared heat to different areas of the consumer's body. The Pad consists of an outer application cover enhanced with precious stones. The Pad's cover is fabricated of faux leather and a standard polyfiber fabric blend.
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