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

    MODEL ES-130

    K Number: K081943 · Decision Nov 24, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    22
    Applicant Total
    8
    Review Days
    139

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    Basic Information

    Device Name
    MODEL ES-130
    K Number
    K081943
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ito Co., Ltd.
    Date Received
    July 8, 2008
    Decision Date
    November 24, 2008
    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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