BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    TENS and EMS Stimulator AK3-25

    Reg #: 3013077196 · FEI: 3013077196 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ASTEK TECHNOLOGY LTD.
    Registration Number
    3013077196
    FEI Number
    3013077196
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.118, Taizih Rd. Rende Hsiang, Tainan Hsien
    City
    Tainan
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K183074

    Owner / Operator

    Firm Name
    ASTEK Technology Ltd.
    Operator Number
    10061317
    Address
    No.118, Taizih Rd. Rende Hsiang, Tainan Hsien
    City
    Tainan
    State
    TW-TNN
    Postal Code
    717
    Country
    TW
    Correspondent
    You-Jhe Lin

    Products

    Device Name Product Code
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
    Stimulator, Muscle, Powered IPF

    Proprietary Names

    TENS and EMS Stimulator AK3-25 TENS Stimulator AK-10M TENS and EMS Stimulator AK3-20 TENS and EMS Stimulator AK3-50

    Establishment Types

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