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

    Everyway OTC TENS/EMS Combination

    K Number: K192589 · Decision Dec 19, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    29
    Review Days
    90

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Everyway OTC TENS/EMS Combination
    K Number
    K192589
    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
    September 20, 2019
    Decision Date
    December 19, 2019
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NUH), ordered by most recent decision date.

    TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)

    FDA 510(k)
    FDA Class 2 ·Neurology

    TENS/EMS device (GUSE01)

    FDA 510(k)
    FDA Class 2 ·Neurology

    TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)

    FDA 510(k)
    FDA Class 2 ·Neurology

    TENS&EMS (HZ9151B, HZ9151C, HZ9151D)

    FDA 510(k)
    FDA Class 2 ·Neurology

    VEINOPLUS Back

    FDA 510(k)
    FDA Class 2 ·Neurology

    Transcutaneous Electrical Nerve Stimulator (RJTENS-2)

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Everyway Medical Instruments Co.,Ltd

    K Number Device Name
    K251856 Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
    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
    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 →