Search Results
Found 42 results
510(k) Data Aggregation
K Number
K162566Device 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
880.5580Why did this record match?
Search-Everything :
Matched: '880.5580'
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.
Ask a Question
K Number
K142760Device 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
880.5580Why did this record match?
Search-Everything :
Matched: '880.5580'
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).
Ask a Question
K Number
K150903Device 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
880.5580Why did this record match?
Search-Everything :
Matched: '880.5580'
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.
Ask a Question
K Number
K142920Device Name
KM Needles (Acupuncture Needle)
Manufacturer
K.M.S. INC.
Date Cleared
2015-06-10
(245 days)
Product Code
MQX
Regulation Number
880.5580Why did this record match?
Search-Everything :
Matched: '880.5580'
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.
Ask a Question
K Number
K141473Device Name
SMC ACUPUNCTURE NEEDLE
Manufacturer
SMC INTL., INC.
Date Cleared
2014-08-01
(59 days)
Product Code
MQX
Regulation Number
880.5580Why did this record match?
Search-Everything :
Matched: '880.5580'
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).
Ask a Question
K Number
K132896Device 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
880.5580Why did this record match?
Search-Everything :
Matched: '880.5580'
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
Ask a Question
K Number
K111392Device Name
WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)
Manufacturer
WOOJEON COMPANY
Date Cleared
2011-11-04
(170 days)
Product Code
MQX, MOX
Regulation Number
880.5580Why did this record match?
Search-Everything :
Matched: '880.5580'
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)
Ask a Question
K Number
K103061Device 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
880.5580Why did this record match?
Search-Everything :
Matched: '880.5580'
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
Ask a Question
K Number
K092240Device Name
ACUPUNCTURE NEEDLES
Manufacturer
HAENGLIM SEOWON MEDICAL CO.
Date Cleared
2010-04-21
(272 days)
Product Code
MQX, CLA
Regulation Number
880.5580Why did this record match?
Search-Everything :
Matched: '880.5580'
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).
Ask a Question
K Number
K090199Device Name
JIAJIAN ACUPUNCTURE NEEDLE
Manufacturer
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
Date Cleared
2009-08-11
(196 days)
Product Code
MQX
Regulation Number
880.5580Why did this record match?
Search-Everything :
Matched: '880.5580'
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.
Ask a Question
Page 1 of 5