Data / Medical devices / Australia / Better Breathing Devices Pty Ltd
Better Breathing Devices Pty Ltd: FDA-registered device maker in Tweed Heads South New South Wales, Australia, 1 510(k) clearance
Better Breathing Devices Pty Ltd is registered with the FDA (registration 3015269903) in Tweed Heads South New South Wales, Australia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 15, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015269903
- Address
- Suite A 13-17 Rivendell Drive, Tweed Heads South New South Wales, Australia, 2486
- Owner or operator
- AirPhysio Pty Ltd (10063104)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- February 10, 2021
- Registered through
- 2026
- Brand names listed
- AirPhysio Health and Wellness, AirPhysio Low Lung Device, AirPhysio Mucus Clearance Device, AirPhysio OPEP Device, AirPhysio Sport, AirPhysio with Travel Case, Better Breathing Kids, Better Breathing Sport and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Percussor, Powered-Electric | BYI | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 15, 2021 | K203209 | AirPhysio Positive Expiratory Pressure (PEP) Device | BYI | Substantially Equivalent | Airphysio Pty, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 15, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.