Baby Health Care, Inc. offers both consumer and medical products, based on regulatory clearances applicable to our Products. Buyers should be aware of the differences between the two. Many of our Products are consumer items and not medical devices; they are not intended to be used as or replace medical devices. They neither diagnose, cure, treat, alleviate, nor prevent any disease or health condition, nor do they investigate, replace, or modify anatomy or physiological processes.
Baby Health Care, Inc. also provides medical products that have been cleared or approved by governmental regulatory bodies and are classified and registered as medical devices. Product documentation will specify if a Product is classified as a medical device. Such products have been tested, validated, and affirmed to meet specific quality and safety standards by regulatory bodies and are held to a higher standard than non-cleared devices. Instructions for use, handling, maintenance, and performance will be provided separately, and users are expected to review and follow this documentation. Our medical products may require a prescription and, in such cases, may only be used for the child for whom the prescription was issued.
OUR PRODUCTS DO NOT OFFER ANY MEDICAL ADVICE OR OPINIONS AND ARE NOT A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU MAY SHARE INFORMATION AND REPORTS FROM OUR PRODUCTS WITH MEDICAL PROFESSIONALS AT YOUR OWN RISK, UNDERSTANDING THAT THE PRODUCTS COME WITHOUT WARRANTY EXCEPT AS REQUIRED BY LAW OR EXPRESSLY SET FORTH IN THIS AGREEMENT.
None of our Products are intended for emergency use. If you think you or your child may have a medical emergency, contact your doctor or emergency services immediately. Never ignore professional advice or delay seeking treatment based on information from our Products.
07/01/2024