BEUDAMED
    FDA Registration Active 🇨🇳 China

    PL-029K8-P2

    Reg #: 3009437400 · FEI: 3009437400 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    3

    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
    K153520

    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
    Stimulator, Electrical, Transcutaneous, For Arthritis NYN

    Proprietary Names

    PL-029K8-P2 PL-029K8-P1 EMS PMS TENS PL-029K5 PL-029K8 PL-029K9 Electronic Pulse Stimulator, also called FlexTone FlexAbs and FlexBody FlexTone FlexAbs FlexBody FlexTone FlexAbs FlexTone FlexBody Easy@Home Mini Wireless TENS Pulse Stimulator EHE015 Easy@Home Electronic Pain Relief Stimulator EHE019

    Establishment Types

    Manufacture Medical Device