BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607

    K Number: K033544 · Decision Dec 10, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    29
    Review Days
    30

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    Basic Information

    Device Name
    ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607
    K Number
    K033544
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Everyway Medical Instruments Co.,Ltd
    Date Received
    November 10, 2003
    Decision Date
    December 10, 2003
    Product Code
    IPF
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IPF Stimulator, Muscle, Powered

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