Better Breathing Devices Pty Ltd · 89-08 · AUSTRALIA
For Better Breathing Devices Pty Ltd, import alert is 89-08; country is AUSTRALIA; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Better Breathing Sport | Better Breathing Kids | Better Breathing Sport | Better Breathing Kids; product code is 73 B - - WF Spirometer, Therapeutic (Incentive) | 73 B - - WF Spirometer, Therapeutic (Incentive) | 73 B - - YI Percussor, Powered-Electric | 73 B - - YI Percussor, Powered-Electric; date published is 10/16/2023; address is Suite A 13-17 Rivendell Drive , Tweed Heads South, New South Wales AUSTRALIA, verified against its source on 2026-09-30.
- Firm
- Better Breathing Devices Pty Ltd verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- AUSTRALIA verified
- Address
- Suite A 13-17 Rivendell Drive , Tweed Heads South, New South Wales AUSTRALIA verified
- Date published
- 10/16/2023 verified
- Product code
- 73 B - - WF Spirometer, Therapeutic (Incentive) | 73 B - - WF Spirometer, Therapeutic (Incentive) | 73 B - - YI Percussor, Powered-Electric | 73 B - - YI Percussor, Powered-Electric each item verified
- Product
- Better Breathing Sport | Better Breathing Kids | Better Breathing Sport | Better Breathing Kids each item verified
What the source says
Better Breathing Devices Pty Ltd Date Published : 10/16/2023 Suite A 13-17 Rivendell Drive , Tweed Heads South, New South Wales AUSTRALIA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
73 B - - WF Spirometer, Therapeutic (Incentive) Date Published: 10/16/2023 Desc: Better Breathing Sport 73 B - - WF Spirometer, Therapeutic (Incentive) Date Published: 10/16/2023 Desc: Better Breathing Kids 73 B - - YI Percussor, Powered-Electric Date Published: 10/16/2023 Desc: Better Breathing Sport 73 B - - YI Percussor, Powered-Electric Date Published: 10/16/2023 Desc: Better Breathing Kids
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html