BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    ACUPUNCTURE INSOLES

    K Number: K840995 · Decision Mar 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    19

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    Basic Information

    Device Name
    ACUPUNCTURE INSOLES
    K Number
    K840995
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Lu LU Enterprise Co. , Ltd.
    Date Received
    March 8, 1984
    Decision Date
    March 27, 1984
    Product Code
    BWK
    Advisory Committee
    Unknown
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BWK Stimulator, Electro-Acupuncture

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