LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    WOOJEON COMPANY

    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

    Page 1 of 1