BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Entre Model PD08-U

    Reg #: 3004183730 · FEI: 3004183730 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TACTILE SYSTEMS TECHNOLOGY INC
    Registration Number
    3004183730
    FEI Number
    3004183730
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    151 5th Ave NW Suite 100
    City
    New Brighton
    State
    MN
    ZIP
    55112
    Country
    US

    Regulatory Submissions

    510(k) Number
    K143185

    Owner / Operator

    Firm Name
    TACTILE SYSTEMS TECHNOLOGY INC
    Operator Number
    9056600
    Address
    3701 Wayzata Blvd, Suite 300
    City
    Minneapolis
    State
    MN
    Postal Code
    55416
    Country
    US
    Correspondent
    Sunday Hoy

    Products

    Device Name Product Code
    Sleeve, Limb, Compressible JOW

    Proprietary Names

    Entre Model PD08-U Entre Plus Model PD08-NG

    Establishment Types

    Manufacture Medical Device