BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    WINBACK GO EAST Co Ltd

    Reg #: 3016512343 · FEI: 3016512343 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    WINBACK GO EAST Co Ltd
    Registration Number
    3016512343
    FEI Number
    3016512343
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    161, Usangongdan-Gil
    City
    Wonju-si Gangwon
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K230167

    Owner / Operator

    Firm Name
    WINBACK GO EAST Co Ltd
    Operator Number
    10062809
    Address
    161, Usangongdan-gil
    City
    Wonju-si
    State
    Gangwon
    Postal Code
    26335
    Country
    KR
    Correspondent
    Daisy Jeong

    US Agent

    Business Name
    FDC Services LLC
    Contact Name
    David FURR
    Address
    7120 Via Correto Dr
    City
    Austin
    State
    TX
    ZIP
    78749
    Country
    US
    Email
    [email protected]
    Phone
    512 9069654

    Products

    Device Name Product Code
    Massager, Vacuum, Radio Frequency Induced Heat PBX
    Stimulator, Muscle, Powered IPF

    Proprietary Names

    BACK 4 Massager, Radiofrequency Induced Heat Winback Back 3SE Hi-TENS Back 3 Color BACK 3TX BACK 3

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device