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

    AXUS ES-5 Electro-Acupuncture Device

    K Number: K200636 · Decision Feb 3, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    22
    Applicant Total
    8
    Review Days
    330

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    Basic Information

    Device Name
    AXUS ES-5 Electro-Acupuncture Device
    K Number
    K200636
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lhasa Oms, Inc.
    Date Received
    March 10, 2020
    Decision Date
    February 3, 2021
    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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