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510(k) Data Aggregation

    K Number
    K033555
    Device Name
    KENKOWAVE INFRARED PAIN TREATMENT SYSTEM
    Manufacturer
    KAYLIGHT CORPORATION
    Date Cleared
    2004-03-02

    (111 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The KenkoWave Infrared Treatment System is a non-invasive, portable, home use device intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, minor arthritis pain, muscle spasm, relieving stiffness and promoting relaxation of the muscle tissue.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter for the KenkoWave Infrared Treatment System. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics. The letter focuses on the FDA's determination of substantial equivalence to a predicate device, allowing the manufacturer to market the product.

    Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications from this document. This letter is a regulatory approval, not a scientific study report.

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