Owlet sells both consumer and medical products, based upon regulatory clearances, as applicable for our Products. Our purchasers should be mindful of the differences between the two. Many of our Products are consumer products and are not medical devices, are not intended for use as a medical device or to replace a medical device. They do not and are not intended to diagnose, cure, treat, alleviate or prevent any disease or health condition or investigate, replace or modify anatomy or any physiological process.
Owlet also sells medical products, which are those products which have been cleared or approved by governmental regulatory bodies and are classified and registered as medical devices. Our product documentation will inform you of the Product’s classification as a medical product. In these cases, by virtue of such clearance, approval, classification or registration, those products have been tested, validated and affirmed to meet certain quality and safety standards by appropriate regulatory bodies, and are held to a higher standard than devices which have not met these standards. In these cases, the instructions for use, handling, maintenance and performance will be subject to separate information and labeling provided to you by Owlet separately with those Products, and users of such Products are expected to review and abide by that documentation. Our medical products may require a prescription, and in those cases, such medical products may only be used by you for the child whom the prescription was issued.
OUR PRODUCTS DO NOT PROVIDE ANY MEDICAL ADVICE OR OPINIONS AND DO NOT SERVE AS A SUBSTITUTE FOR THE ADVICE OF A MEDICAL PROFESSIONAL. YOU MAY PROVIDE THE INFORMATION AND REPORTS DISPLAYED IN OUR PRODUCTS TO MEDICAL PROFESSIONALS AT YOUR OWN RESPONSIBILITY, UNDERSTANDING THAT THE PRODUCTS ARE PROVIDED WITHOUT WARRANTY EXCEPT AS REQUIRED BY LAW OR AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT.
None of the Products are intended for emergency situations. If you think you OR YOUR CHILD may have a medical emergency, call your doctor or emergency services immediately. Never disregard professional advice or delay in seeking treatment or advice because of information you receive from the Products or read about the Products.