BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TENSUNITS

    Reg #: 3014647250 · FEI: 3014647250 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    FASHIONABLE, INC.
    Registration Number
    3014647250
    FEI Number
    3014647250
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12399 S. Belcher Rd, Suite 160
    City
    Largo
    State
    FL
    ZIP
    33773
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121719

    Owner / Operator

    Firm Name
    Fashionable, Inc.
    Operator Number
    10058021
    Address
    12399 S. Belcher Rd, Suite 160
    City
    Largo
    State
    FL
    Postal Code
    33773
    Country
    US
    Correspondent
    Tina Wagner

    Products

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

    Proprietary Names

    TENSUNITS

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198