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

    EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908

    K Number: K110509 · Decision Jun 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    72
    Applicant Total
    29
    Review Days
    118

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    Basic Information

    Device Name
    EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908
    K Number
    K110509
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Everyway Medical Instruments Co.,Ltd
    Date Received
    February 22, 2011
    Decision Date
    June 20, 2011
    Product Code
    LIH
    Advisory Committee
    Neurology
    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
    LIH Interferential Current Therapy

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    Other Clearances by Everyway Medical Instruments Co.,Ltd

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    K202470 Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300
    K202317 Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806
    K201335 Li-Battery powered OTC TENS/EMS Combination Stimulator
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