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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
K.M.S. INC.
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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