BEUDAMED
    FDA Registration Active 🇨🇳 China

    Galvanic Spa, Model: SKB-1405

    Reg #: 3007744197 · FEI: 3007744197 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Shenzhen Siken 3D Technology Development Co., Ltd.
    Registration Number
    3007744197
    FEI Number
    3007744197
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Fourth building NO.33 Left East Avenue, Songgang,Bao An District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K163470

    Owner / Operator

    Firm Name
    Shenzhen Siken 3D Technology Development Co., Ltd.
    Operator Number
    10029432
    Address
    Fourth building NO.33 Left East Avenue, Songgang,Bao`an District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518105
    Country
    CN

    US Agent

    Business Name
    IRC USA
    Contact Name
    Charles Mack
    Address
    2950 E Lindrick Dr
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

    Device Name Product Code
    Stimulator, Transcutaneous Electrical, Aesthetic Purposes NFO

    Proprietary Names

    Galvanic Spa, Model: SKB-1405 Nuovaluce Mini Device, Model number 213-MN Aphrona Galvanic SPA-facial toning device; Aphrona EMS microcurrent face lift device

    Establishment Types

    Manufacture Medical Device