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510(k) Data Aggregation

    K Number
    K974122
    Device Name
    ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA
    Manufacturer
    SCIENTIFIC HEALTH CARE
    Date Cleared
    1998-01-22

    (83 days)

    Product Code
    MQX,MOX
    Regulation Number
    880.5580
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HWATO and HUAXIA acupuncture needles are used to pierce skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for an acupuncture needle. It does not contain information about acceptance criteria, device performance, study details, sample sizes, or expert qualifications as requested in your prompt. The text is a regulatory approval document, not a scientific study report.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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