BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Electronic Pulse Stimulator

    K Number: K221992 · Decision Oct 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    14
    Review Days
    107

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    Basic Information

    Device Name
    Electronic Pulse Stimulator
    K Number
    K221992
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beijing Choice Electronic Technology Co., Ltd.
    Date Received
    July 6, 2022
    Decision Date
    October 21, 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 Beijing Choice Electronic Technology Co., Ltd.

    K Number Device Name
    K232975 Pulse Oximeter (MD300C228)
    K230587 Wrist Pulse Oximeter
    K230172 Pulse Oximeter
    K220101 Pulse Oximeter
    K211400 Pulse Oximeter
    K211752 Infrared Thermometer
    K211754 Vital Signs Monitor
    K181503 Fingertip Pulse Oximeter
    K172366 Wrist Pulse Oximeter
    K162089 Blood Pressure Monitor
    Search all 14 clearances from Beijing Choice Electronic Technology Co., Ltd. →