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

    Portable Electro-Stimulation Therapy Device

    K Number: K182108 · Decision Apr 26, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    6
    Review Days
    266

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    Basic Information

    Device Name
    Portable Electro-Stimulation Therapy Device
    K Number
    K182108
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangzhou Longest Science & Technology Co., Ltd.
    Date Received
    August 3, 2018
    Decision Date
    April 26, 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

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    Other Clearances by Guangzhou Longest Science & Technology Co., Ltd.

    K Number Device Name
    K202110 MStim Drop Model: LGT-233
    K201845 Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)
    K182020 Portable Electro-Stimulation Therapy Device
    K191856 Compression Therapy Device
    K191862 Compression Therapy Device Model LGT-2200SP