BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KWELL Electrical Muscle Stimulator Device

    Reg #: 3012477715 · FEI: 3012477715 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OUI LAB INC.
    Registration Number
    3012477715
    FEI Number
    3012477715
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    15362 Valley Blvd
    City
    City of Industry
    State
    CA
    ZIP
    91746
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213116

    Owner / Operator

    Firm Name
    Oui Lab Inc.
    Operator Number
    10083075
    Address
    15362 Valley Blvd
    City
    City of Industry
    State
    CA
    Postal Code
    91746
    Country
    US
    Correspondent
    Weller Chen

    Products

    Device Name Product Code
    Stimulator, Electrical, Non-Implantable, For Incontinence KPI

    Proprietary Names

    KWELL Electrical Muscle Stimulator Device

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198