BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    AirPhysio Positive Expiratory Pressure (PEP) Device

    Reg #: 3015269903 · FEI: 3015269903 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Better Breathing Devices Pty Ltd
    Registration Number
    3015269903
    FEI Number
    3015269903
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Suite A 13-17 Rivendell Drive
    City
    Tweed Heads South New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K203209

    Owner / Operator

    Firm Name
    AirPhysio Pty Ltd
    Operator Number
    10063104
    Address
    13-17 Rivendell Drive, Suite A
    City
    Tweed Heads South
    State
    New South Wales
    Postal Code
    2486
    Country
    AU
    Correspondent
    Paul O'Brien

    US Agent

    Business Name
    FDAbasics LLC
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Percussor, Powered-Electric BYI

    Proprietary Names

    AirPhysio Positive Expiratory Pressure (PEP) Device Handheld Airway Clearance Device Powered Percussor Mucus Clearance Device AirPhysio with Travel Case

    Establishment Types

    Manufacture Medical Device