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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR

    K Number: K113010 · Decision Dec 21, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    6
    Review Days
    437

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    Basic Information

    Device Name
    FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR
    K Number
    K113010
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Famidoc Technology Co., Ltd.
    Date Received
    October 11, 2011
    Decision Date
    December 21, 2012
    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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