BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Omnisound 3000E

    Reg #: 9617486 · FEI: 1000442645 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ZMI ELECTRONICS LTD.
    Registration Number
    9617486
    FEI Number
    1000442645
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6F-1, NO. 286-4, Shin Ya Rd., Chien Chen District,
    City
    KAOHSIUNG
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K883893

    Owner / Operator

    Firm Name
    ZMI ELECTRONICS, LTD.
    Operator Number
    9035676
    Address
    6F-1, NO. 286-4, SHIN YA RD, --
    City
    KAOHSIUNG
    State
    TW-NOTA
    Postal Code
    806
    Country
    TW
    Correspondent
    YUTA - LEE

    Products

    Device Name Product Code
    Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat IMG

    Proprietary Names

    Omnisound 3000E

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)