Better Breathing Devices Pty Ltd
⚠️ High Risk
FEI: 3015269903 • Tweed Heads South, New South Wales • AUSTRALIA
FEI Number
3015269903
Location
Tweed Heads South, New South Wales
Country
AUSTRALIAAddress
Suite A 13-17 Rivendell Drive, , Tweed Heads South, New South Wales, Australia
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/1/2025 | 73BYIPERCUSSOR, POWERED-ELECTRIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/13/2023 | 73BYIPERCUSSOR, POWERED-ELECTRIC | Division of West Coast Imports (DWCI) | |
| 11/13/2023 | 73BYIPERCUSSOR, POWERED-ELECTRIC | Division of West Coast Imports (DWCI) | |
| 2/17/2023 | 73BYIPERCUSSOR, POWERED-ELECTRIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/7/2022 | 73BYIPERCUSSOR, POWERED-ELECTRIC | Division of Southeast Imports (DSEI) | |
| 11/17/2022 | 73BYIPERCUSSOR, POWERED-ELECTRIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/4/2022 | 73BYIPERCUSSOR, POWERED-ELECTRIC | Division of Northern Border Imports (DNBI) | |
| 3/31/2022 | 73BYIPERCUSSOR, POWERED-ELECTRIC | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Better Breathing Devices Pty Ltd's FDA import refusal history?
Better Breathing Devices Pty Ltd (FEI: 3015269903) has 8 FDA import refusal record(s) in our database, spanning from 3/31/2022 to 8/1/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Better Breathing Devices Pty Ltd's FEI number is 3015269903.
What types of violations has Better Breathing Devices Pty Ltd received?
Better Breathing Devices Pty Ltd has been cited for 8 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Better Breathing Devices Pty Ltd come from?
All FDA import refusal data for Better Breathing Devices Pty Ltd is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.