BEUDAMED
    FDA Registration Active 🇨🇳 China

    TENS unit

    Reg #: 3009437400 · FEI: 3009437400 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    JKH Health Co., Ltd.
    Registration Number
    3009437400
    FEI Number
    3009437400
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3-5F and 11F, Building 14, Tiangong Smart Valley Industrial Park, Fuhai Road, Xiagang Community, ChangAn Town
    City
    Dongguan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K131921

    Owner / Operator

    Firm Name
    JKH Health Co., Ltd.
    Operator Number
    10038935
    Address
    15F, Building 2, Zone 1, Xinqiaodong Advanced Manufacturing Industrial Park, Hongtian Road, Huangpu Community, Xinqiao Street, Baoan District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518125
    Country
    CN
    Correspondent
    Pu Jiang

    Products

    Device Name Product Code
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH

    Proprietary Names

    TENS unit Electronic Pulse Stimulator PL-009 Easy@Home TENS Pulse Stimulator Easy@Home TENS Pain Relief Device, EHE009 PEPULSE-RT TM-1000PRO Easy@Home TENS Pulse Stimulator, EHE010 PETENSPAD Easy@Home Electronic TENS Pulse Stimulator, EHE012PRO PETENSPAD10 PEPULSE PETENSPAD5

    Establishment Types

    Manufacture Medical Device