BEUDAMED
    FDA Registration Active 🇨🇳 China

    Penguin Electronic Pulse TENS EMS (Prospera PL009B reference to KTR-2401)

    Reg #: 3013671142 · FEI: 3013671142 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD
    Registration Number
    3013671142
    FEI Number
    3013671142
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2nd Floor, No. 11, Shanzhuang Road, Xikeng Village, Yuanshan Street, Longgang District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K242332

    Owner / Operator

    Firm Name
    SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD
    Operator Number
    10055119
    Address
    2nd Floor, No. 11, Shanzhuang Road, Xikeng Village, Yuanshan Street, Longgang District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518115
    Country
    CN
    Correspondent
    Zewu Zhang

    US Agent

    Business Name
    MID-LINK INTERNATIONAL Co.,Ltd
    Contact Name
    Marco Mu
    Address
    2219 Rimlang Drive, Suite 301
    City
    Bellingham
    State
    WA
    ZIP
    98226
    Country
    US
    Email
    [email protected]
    Phone
    702 2095185

    Products

    Device Name Product Code
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
    Stimulator, Electrical, Transcutaneous, For Arthritis NYN

    Proprietary Names

    Penguin Electronic Pulse TENS EMS (Prospera PL009B reference to KTR-2401) Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2 Smart Stim

    Establishment Types

    Manufacture Medical Device