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

    NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P

    K Number: K033140 · Decision Oct 29, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    29
    Review Days
    29

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    Basic Information

    Device Name
    NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P
    K Number
    K033140
    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
    September 30, 2003
    Decision Date
    October 29, 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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    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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