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510(k) Data Aggregation

    K Number
    K991507
    Device Name
    KANGNIAN BRAND ACUPUNCTURE NEEDLE
    Manufacturer
    HELIO MEDICAL SUPPLIES, INC.
    Date Cleared
    1999-08-27

    (120 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 :

    KANGNIAN BRAND ACUPUNCTURE NEEDLE

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

    To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

    Device Description

    Kangnian Brand Acupuncture Needle

    AI/ML Overview

    This document is a FDA 510(k) clearance letter for a Kangnian Brand Acupuncture Needle. It does not contain information about the acceptance criteria or a study proving the device meets those criteria, as it is a regulatory approval document rather than a performance study report.

    Therefore, I cannot extract the requested information from the provided text.

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