Reference Source

Better Breathing Devices Pty Ltd · 89-08 · AUSTRALIA

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
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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.