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

    DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS

    K Number: K020749 · Decision Oct 31, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    29
    Review Days
    238

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    Basic Information

    Device Name
    DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS
    K Number
    K020749
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Everyway Medical Instruments Co.,Ltd
    Date Received
    March 7, 2002
    Decision Date
    October 31, 2002
    Product Code
    GZJ
    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
    GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

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    Other Clearances by Everyway Medical Instruments Co.,Ltd

    K Number Device Name
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    K222488 Everyway Analog OTC TENS
    K213116 Everyway Incontinence Stimulation System
    K202849 Everyway Analog OTC TENS, model N103A/N302
    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
    K192589 Everyway OTC TENS/EMS Combination
    K182767 V2 OTC Pain Relief TENS
    K182753 A6 OTC Pain Relief TENS
    Search all 29 clearances from Everyway Medical Instruments Co.,Ltd →