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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?
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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