BEUDAMED
    FDA Registration Active 🇺🇸 United States

    O2Boot, O2Sacral

    Reg #: 3008847017 · FEI: 3008847017 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GWR MEDICAL, INC.
    Registration Number
    3008847017
    FEI Number
    3008847017
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4 Hillman Dr Suite 106
    City
    Chadds Ford
    State
    PA
    ZIP
    19317
    Country
    US

    Regulatory Submissions

    510(k) Number
    K971507

    Owner / Operator

    Firm Name
    GWR Medical, Inc.
    Operator Number
    10035265
    Address
    4 Hillman Drive, Suite 106
    City
    Chadds Ford
    State
    PA
    Postal Code
    19317
    Country
    US
    Correspondent
    Sean Geary

    Products

    Device Name Product Code
    Chamber, Oxygen, Topical, Extremity KPJ

    Proprietary Names

    O2Boot, O2Sacral

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility