BEUDAMED
    FDA Registration Active 🇨🇳 China

    GUANGZHOU HUAKAI ELECTRONIC TECHNOLOGY CO., LTD.

    Reg #: 3012729332 · FEI: 3012729332 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    5

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    Registration Details

    Registration Name
    GUANGZHOU HUAKAI ELECTRONIC TECHNOLOGY CO., LTD.
    Registration Number
    3012729332
    FEI Number
    3012729332
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4th Floor, Building 8, Bigang Ind Zone, Nangang,Huangpu District
    City
    Guangzhou Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K221251

    Owner / Operator

    Firm Name
    Guangzhou HuaKai Electronic Technology Co., Ltd.
    Operator Number
    10050595
    Address
    4th Floor, Building 8, Bigang Ind Zone, Nangang,Huangpu District
    City
    Guangzhou
    State
    Guangdong
    Postal Code
    510730
    Country
    CN
    Correspondent
    Anna Wu

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Massager, Therapeutic, Electric ISA
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Pad, Heating, Powered IRT
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH

    Proprietary Names

    Foot Massager, Huakai Foot Massager, HK-805H, HK-802H, HK-803A, HK-805B, HK-807, HK-818, HK-809, HK-802FS, HK-805C, HK-803, HK-805D, HK-805A, 807D, 803B, HK-710A, HK-710B, HK-710C, HK-710D, HK-801A, HK-801B, HK-801M, HK-712 HK-807D, HK-802Pro, HK-712P, HK-730 Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)

    Establishment Types

    Manufacture Medical Device