BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    OTC Combo TENS/EMS System, model WL-2405G & WL-2405H

    Reg #: 3006850006 · FEI: 3006850006 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Well-Life Healthcare Limited
    Registration Number
    3006850006
    FEI Number
    3006850006
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6F., No.168, Lide St.,
    City
    Jhonghe Taipei
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K172809

    Owner / Operator

    Firm Name
    Well-Life Healthcare Limited
    Operator Number
    10023740
    Address
    6F., No. 168, Lide St.,
    City
    Jhonghe
    State
    Taipei
    Postal Code
    235
    Country
    TW
    Correspondent
    Chin-Chih Hsieh

    US Agent

    Business Name
    ProMedic, Inc.
    Contact Name
    Paul E. Dryden
    Address
    131 Bay Point Dr. NE
    City
    Saint Petersburg
    State
    FL
    ZIP
    33704
    Country
    US
    Email
    [email protected]
    Phone
    239 3076063

    Products

    Device Name Product Code
    Stimulator, Electrical, Transcutaneous, For Arthritis NYN
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH

    Proprietary Names

    OTC Combo TENS/EMS System, model WL-2405G & WL-2405H PlayMakar, Model Pro-500

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)