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510(k) Data Aggregation

    K Number
    K962809
    Device Name
    SEIRIN ACUPUNCTURE NEEDLES
    Manufacturer
    SEIRIN-AMERICA, INC.
    Date Cleared
    1996-08-16

    (29 days)

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

    SEIRIN ACUPUNCTURE NEEDLES

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

    Acupuncture needles are defined as devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

    Device Description

    The subject of this 510(k) application - the Seirin acupuncture needle - is a sterile, single use only acupuncture needle. The Seirin acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.

    AI/ML Overview

    The provided document is a 510(k) summary for acupuncture needles and does not contain the kind of information requested regarding acceptance criteria, study details, and performance metrics typically associated with modern AI/ML medical devices.

    Therefore, I cannot answer your request based on the input document. The document describes a traditional medical device (acupuncture needles) and focuses on demonstrating substantial equivalence to previously marketed devices, rather than providing performance data for a new AI-powered diagnostic or therapeutic tool.

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