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510(k) Data Aggregation

    K Number
    K043306
    Device Name
    SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR
    Manufacturer
    SKYLARK DEVICE & SYSTEMS CO., LTD
    Date Cleared
    2005-06-06

    (187 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR

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

    To provide infrared lamp energy that penetrates the skin to promote increased blood flow and circulation, thereby, providing temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, and muscle spasm. The elevated tissue temperature also promotes relaxation of muscles of muscles and relief from pain resulting in improved range of motion.

    Device Description

    Skylark Infrared Lamp, Models SD-956IR and SD-100IR

    AI/ML Overview

    This looks like a 510(k) clearance letter for an infrared lamp, not a study report for a medical device with performance metrics. The provided document is an FDA clearance letter for a device, not a study describing acceptance criteria and performance data. Therefore, I cannot extract the requested information about device performance and study methodology.

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