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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?
    Product Code :

    MQX

    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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    K Number
    K142760
    Device Name
    Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles
    Manufacturer
    K.S. Choi Corporation
    Date Cleared
    2015-08-25

    (334 days)

    Product Code
    MQX
    Regulation Number
    880.5580
    Why did this record match?
    Product Code :

    MQX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Our acupuncture needles are devices used by licensed practitioners and are 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 sterile, thin needles which are inserted into specific points on the skin called "acupuncture points." The Acupuncture Needles are manufactured from stainless steel and sterilized with ethylene oxide gas. Acupuncture is the stimulation of specific acupuncture points along the skin of the body involving various methods such as penetration by thin needles. The skin is sterilized, such as with alcohol, and the needles are inserted, frequently with a plastic guide tube for the user. Needles may be manipulated in various ways including spinning, flicking, or moving up and down relative to the skin. The Acuzone Acupuncture Needles and KSC DB Plus Acupuncture Needles are made of surgical stainless steel, a handle consisting of a flexible coiled copper handle with nickel plated for protection, or a surgical stainless steel or aluminum tube handle and may be provided with a plastic guide tube. (10pcs/pack, 1000pcs/box). Acuzone press tack needles (with micropore tape) are made with surgical stainless steel (10pcs/ pack, 100pcs/box). AcuZone Intradermal Needles are made with surgical stainless steel (5pcs/pack, 100pcs/box). Press tack and intradermal needles have same purpose for ear acupuncture point. The Acupuncture needles are available in nine diameters (0.12 ~ 0.35mm), five needle lengths (15 ~ 60mm), and tube lengths (30mm, 45mm, 55mm, 65mm and 75mm). Acuzone press tack needle is available in one diameter (0.20mm x 2mm x length (1mm). AcuZone Intradermal Needles is available in one diameter (0.12mm), one length (5mm).
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    K Number
    K150903
    Device Name
    EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural
    Manufacturer
    MAANSHAN BOND MEDICAL INSTRUMENTS CO., LTD.
    Date Cleared
    2015-07-15

    (103 days)

    Product Code
    MQX
    Regulation Number
    880.5580
    Why did this record match?
    Product Code :

    MQX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have attached to the needle to facilitate the deliyery of acupuncture treatment.
    Device Description
    The device consists of a solid, stainless steel needle. The device may have attached to the needle to facilitate the deliyery of acupuncture treatment.
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    K Number
    K142920
    Device Name
    KM Needles (Acupuncture Needle)
    Manufacturer
    K.M.S. INC.
    Date Cleared
    2015-06-10

    (245 days)

    Product Code
    MQX
    Regulation Number
    880.5580
    Why did this record match?
    Product Code :

    MQX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This KM Needles (Acupuncture Needle) is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the state regulations.
    Device Description
    The KM Needles (Acupuncture Needle) are simple stainless steel pins that are used by an acupuncture practioner in the treatment of various conditions. Acupuncture is the timulation of specific acupuncture points along the skin of the body involving various methods such as penetration by thin needles or the application of heat, pressure, or laser light. Clinical practice varies depending on the country. Traditional acupuncture involves needle insertion, moxibustion, and cupping therapy. It is a form of alternative medicine and a key component of traditional Chinese medicine (TCM). The KM Needles (Acupuncture Needle) are constructed of stainless steel, with pin body diameters ranging from 0.16 to 0.70 mm and vary in length from 15 to 135 mm. Each acupuncture needle has a handle for the practioner to manipulate the needle. The handle is also made from stainless steel and range in length from 20-30 mm.
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    K Number
    K141473
    Device Name
    SMC ACUPUNCTURE NEEDLE
    Manufacturer
    SMC INTL., INC.
    Date Cleared
    2014-08-01

    (59 days)

    Product Code
    MQX
    Regulation Number
    880.5580
    Why did this record match?
    Product Code :

    MQX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SMC ACUPUNCTURE NEEDLE 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 sterile, hair thin needles which are inserted into specific points on the skin, called "acupuncture points". The Acupuncture Needles are manufactured from stainless steel and sterilized with gamma irradiation and/or ethylene oxide. The Acupuncture Needles are available in nine needle diameters (0.16 to 0.70 mm), ten needle lengths (15-135 mm), and ten tube lengths (30-160 mm).
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    K Number
    K132896
    Device Name
    CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE
    Manufacturer
    ASIA-MED GMBH AND CO KG
    Date Cleared
    2013-12-02

    (77 days)

    Product Code
    MQX
    Regulation Number
    880.5580
    Why did this record match?
    Product Code :

    MQX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TeWa Acupuncture Needle is a device intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
    Device Description
    Not Found
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    K Number
    K111392
    Device Name
    WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)
    Manufacturer
    WOOJEON COMPANY
    Date Cleared
    2011-11-04

    (170 days)

    Product Code
    MQX, MOX
    Regulation Number
    880.5580
    Why did this record match?
    Product Code :

    MQX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WOOJEON ACUPUNCTURE NEEDLES is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states
    Device Description
    The our needles are sterile which are inserted into specific points on the skin, called "acupuncture points." The Acupuncture Needles are manufactured from stainless steel and sterilized with gamma irradiation. The Acupuncture Needles are available in 78 models as per diameters (0.16 to 0.40 mm) and 78 needle tube models as per lengths (8-60mm)
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    K Number
    K103061
    Device Name
    BIOMATE STERILE ACUPUNCTURE NEEDLE
    Manufacturer
    BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD.
    Date Cleared
    2011-06-20

    (245 days)

    Product Code
    MQX, MOX
    Regulation Number
    880.5580
    Why did this record match?
    Product Code :

    MQX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Biomate Sterile Acupuncture Needle, Model: Nano, Nano-PI, Nano-EI is intended to be used to pierce the skin in the practice of acupuncture (by qualified practitioner of acupuncture) as determined by the States.
    Device Description
    Not Found
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    K Number
    K092240
    Device Name
    ACUPUNCTURE NEEDLES
    Manufacturer
    HAENGLIM SEOWON MEDICAL CO.
    Date Cleared
    2010-04-21

    (272 days)

    Product Code
    MQX, CLA
    Regulation Number
    880.5580
    Why did this record match?
    Product Code :

    MQX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device 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 sterile, hair thin needles which are inserted into specific points on the skin, called "acupuncture points." The Acupuncture Needles are manufactured from stainless steel and sterilized with gamma irradiation. The Acupuncture Needles are available in eleven diameters (0.14 to 0.50 mm), nine needle lengths (15-60mm), two stick lengths (20 and 30 mm), and nine tube lengths (30-145 mm).
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    K Number
    K090199
    Device Name
    JIAJIAN ACUPUNCTURE NEEDLE
    Manufacturer
    WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
    Date Cleared
    2009-08-11

    (196 days)

    Product Code
    MQX
    Regulation Number
    880.5580
    Why did this record match?
    Product Code :

    MQX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Jiajian Acupuncture Needle is intended to piece the skin in the practice of acupuncture therapy by qualified practitioners or acupuncture doctors as determined by the states.
    Device Description
    Jiajian brand Acupuncture Needle consists of a stainless steel wire (ASTM 304) as the needle body, with a stainless steel wire handle, a copper wire handle or polystyrol handle. The handles make the needles easier to manipulate and place. The acupuncture needle is sterilized and disposable. The diameter of the needle is 0.14~0.80mm; the length of the needle is 7~100mm; the invasive length is 2~47mm.
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