Reference Source

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
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

— 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

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