Legal Disclaimer – BREATHEEZE PERFORMANCE

Important Notice
BREATHEEZE PERFORMANCE products are intended for personal wellness use and are not intended to diagnose, treat, cure, or prevent any medical condition. The information provided on this website is for general informational purposes only and is not a substitute for professional medical advice. Always consult a qualified healthcare professional before using any BREATHEEZE PERFORMANCE product.

Compliance Statement
BREATHEEZE PERFORMANCE Nasal Strips and Mouth Tape Devices are listed with the Therapeutic Goods Administration (TGA) in Australia under the following ARTG numbers:

• ARTG 430850

• ARTG 471527

Our products also comply with medical device regulations in:

• The European Union under Regulation (EU) 2017/745 (Annexes II and III), and

• The U.S. Food and Drug Administration (FDA) under Device Listing Number D518832.

Applicable Standards
These products are manufactured in accordance with applicable international standards:
EN ISO14971:2019, EN ISO15223-1:2021, EN ISO20417:2021, EN ISO10993-1:2020, EN ISO10993-5:2009, EN ISO10993-10:2013, ISO9001, ISO13485

Product Use and Consumer Responsibility
BREATHEEZE PERFORMANCE products are intended for home and personal use only and should be used in strict accordance with the instructions provided on our website and in the product leaflet. Children under the age of 18 should use BREATHEEZE PERFORMANCE products only under the supervision of a parent or guardian. We do not recommend the use of BREATHEEZE PERFORMANCE Mouth Tape for children under 12 years of age due to potential risks during sleep. Use is entirely at your own risk, and we strongly recommend consulting a healthcare professional to determine suitability before use.

Medical Device Disclaimer
Although our products are registered as medical devices with the TGA, FDA, and CE, they are intended for general wellness support and do not replace professional medical treatment or advice.

User Acknowledgement
By using any BREATHEEZE PERFORMANCE product, you acknowledge that you have read and understood all instructions, warnings, and precautions, the potential risks, and that you are solely responsible for safe and appropriate use of the product.

Health Conditions – Do Not Use If You Have Any of the Following:
Obstructive Sleep Apnea (diagnosed or suspected), difficulty breathing through the nose, asthma or chronic respiratory conditions, obesity with a BMI over 35, cold, sinus, or ear infections, non-intact skin, chapped lips, or mouth wounds, alcohol or sedative consumption, vomiting issues (e.g. gastric emesis), severe cardiovascular or respiratory issues, very low blood pressure, or difficulty breathing or swallowing.

Mouth Tape Warning:
Use during sleep may carry risks of airway obstruction. Cease use immediately if you experience difficulty breathing, chest pain, dizziness, or nausea, and seek medical attention.

Removal Instructions
To reduce skin irritation, remove products slowly, ideally while in a moist environment (e.g., shower). If removal is difficult, apply water to loosen the adhesive.

No Medical Advice
Any descriptions, FAQs, or content provided by BREATHEEZE PERFORMANCE are for informational purposes only and do not constitute medical advice.

Disclaimer of Liability
To the maximum extent permitted by law, One Piece Corporations Pty Ltd as trustee for The One Piece Trust (ABN: 35 842 281 933), trading as BREATHEEZE PERFORMANCE (“the Company”) is not liable for any direct, indirect, incidental, special, consequential, or exemplary damages resulting from use or misuse of our products.

Indemnity
Users agree to indemnify and hold harmless the Company, its directors, officers, employees, and affiliates from any claims, damages, losses, or liabilities arising from use or misuse of BREATHEEZE PERFORMANCE products.

Consumer Law – Important
Nothing in this disclaimer excludes, restricts, or modifies any consumer guarantee, right, or remedy conferred by the Australian Consumer Law (ACL) or any other applicable legislation that cannot be excluded, restricted, or modified by agreement.

Governing Law
This disclaimer and any related disputes are governed by the laws of Australia, without regard to its conflict of law provisions.

Contact Information
For concerns about product quality, adverse reactions, or to request product support, please contact:
support@breatheeze.com.au