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510(k) Data Aggregation

    K Number
    K162566
    Device Name
    AIK Sterile Acupuncture Needles for Single Use
    Manufacturer
    CHANGCHUN AIK MEDICAL DEVICES CO., LTD
    Date Cleared
    2017-05-11

    (239 days)

    Product Code
    MQX
    Regulation Number
    880.5580
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHANGCHUN AIK MEDICAL DEVICES CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AIK Sterile Acupuncture Needles for Single Use is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
    Device Description
    The Acupuncture Needles are manufactured from stainless steel and sterilized with ethylene oxide gas. Acupuncture needle is made up of needle handle and needle body. The body of needle uses 304 stainless steel wire (06Cr19Ni10). The handle is a body coil with stainless steel wire, the spiral loop of which is arranged symmetrically without gaps. The device can only be used by qualified practitioners of acupunctures. Qualified practitioners should already be knowledgeable on how to use the acupuncture needle and when not to use acupuncture in certain patient populations and medical conditions. Handle of acupuncture needle is a plain handle. Types of acupuncture needle (sterile acupuncture needle for single use) are: acupuncture needle without a guide tube and acupuncture needle with a guide tube.
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