# Better Breathing Devices Pty Ltd · 89-08 · AUSTRALIA — FDA import alert red lists: firms subject to detention without physical examination

For Better Breathing Devices Pty Ltd · 89-08 · AUSTRALIA, import alert is 89-08; 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)"; country is AUSTRALIA; 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 2026-09-16.

- **Firm:** Better Breathing Devices Pty Ltd _(verified: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Suite A 13-17 Rivendell Drive , Tweed Heads South, New South Wales AUSTRALIA _(verified: appears in the quote below)_
- **Date published:** 10/16/2023 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **Product:** Better Breathing Sport | Better Breathing Kids | Better Breathing Sport | Better Breathing Kids _(verified: each item appears in the quote below)_

## 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 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).