BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PainPod ultra

    Reg #: 3003895865 · FEI: 3003895865 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HI-DOW INTERNATIONAL INC.
    Registration Number
    3003895865
    FEI Number
    3003895865
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2555 Metro Blvd
    City
    Maryland Heights
    State
    MO
    ZIP
    63043
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233461

    Owner / Operator

    Firm Name
    Hi-Dow International Incorporated
    Operator Number
    9052765
    Address
    2555 Metro Blvd, --
    City
    Maryland Heights
    State
    MO
    Postal Code
    63043
    Country
    US
    Correspondent
    Eric Y Chen

    Products

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

    Proprietary Names

    PainPod ultra Pro-Touch Wireless 6-12

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198