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510(k) Data Aggregation

    K Number
    K121487
    Manufacturer
    Date Cleared
    2012-06-12

    (25 days)

    Product Code
    Regulation Number
    890.5500
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LITECURE THERAPY COMPACT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    LiteCure Therapy Compact (Model LTC-900 and LTC-1200) is indicated for emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) summary from the FDA for a medical device called "Litecure Therapy Compact." It does not contain information about acceptance criteria or a study that proves the device meets those criteria, nor does it provide details about AI algorithms, sample sizes for training/test sets, expert involvement, or adjudication methods.

    The document is a letter confirming the substantial equivalence of the Litecure Therapy Compact (Models LTC-900 and LTC-1200) to legally marketed predicate devices, a necessary step for FDA clearance. It lists the indications for use, which are to provide topical heating for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, promoting relaxation of muscle tissue, and temporarily increasing local blood circulation.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details. That information is not present in the provided document.

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