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510(k) Data Aggregation

    K Number
    K990406
    Device Name
    KINGLI ACUPUNCTURE NEEDLE
    Manufacturer
    UNITED PACIFIC CO., LTD.
    Date Cleared
    1999-04-16

    (66 days)

    Product Code
    MQX,MOX
    Regulation Number
    880.5580
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KINGLI ACUPUNCTURE NEEDLE

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

    to pierce the skin in the practice of acupuncture by the states.

    Device Description

    DISPOSABLE ACUPUNCTURE NEEDLE

    AI/ML Overview

    I am unable to answer your request. The provided text is a 510(k) clearance letter from the FDA for an acupuncture needle, and it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions you've asked. The document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not detail the technical performance evaluation or study design typically associated with demonstrating how a device meets specific acceptance criteria.

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