BEUDAMED
    FDA Registration Active 🇨🇳 China

    Biofeedback Nerve and Muscle Stimulator (Models: KM530B, KM531B, KM536, KM537)

    Reg #: 3011905669 · FEI: 3011905669 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SHENZHEN KONMED TECHNOLOGY CO., LTD
    Registration Number
    3011905669
    FEI Number
    3011905669
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    601, Building B4, Shenchengtou creative factory life science park, Julongshan A Road, Xiuxin block, Kengzi Street, Pingshan District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K220161

    Owner / Operator

    Firm Name
    Shenzhen Konmed Technology Co., Ltd
    Operator Number
    10054707
    Address
    601, Building B4, Shenchengtou creative factory life science park, Julongshan A Road, Xiuxin block, Kengzi Street, Pingshan District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518118
    Country
    CN
    Correspondent
    Shui Shan Yin

    US Agent

    Business Name
    Performance International, Corp.
    Contact Name
    DENNIS XU DENNIS XU
    Address
    2816 Sunset Ave
    City
    Rocky Mount
    State
    NC
    ZIP
    27804
    Country
    US
    Email
    [email protected]
    Phone
    919 8590478

    Products

    Device Name Product Code
    Device, Biofeedback HCC
    Stimulator, Electrical, Non-Implantable, For Incontinence KPI

    Proprietary Names

    Biofeedback Nerve and Muscle Stimulator (Models: KM530B, KM531B, KM536, KM537)

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198