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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Everyway Analog OTC TENS

    K Number: K222488 · Decision Nov 15, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    29
    Review Days
    90

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    Basic Information

    Device Name
    Everyway Analog OTC TENS
    K Number
    K222488
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Everyway Medical Instruments Co.,Ltd
    Date Received
    August 17, 2022
    Decision Date
    November 15, 2022
    Product Code
    NUH
    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
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

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    Other Clearances by Everyway Medical Instruments Co.,Ltd

    K Number Device Name
    K251856 Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
    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
    K181707 Everyway Wireless TENS & EMS Unit
    Search all 29 clearances from Everyway Medical Instruments Co.,Ltd →