FDA Regulations

AURA Wellness is currently registered with the FDA as a manufacturer of medical devices. Having our device facility and listing our devices does not, in any way, constitute FDA endorsement of our products.

Our products fall under the Product Code “ISA” with the Regulation Number “890.5660”. Aura devices are to be used as massage-like instruments; there are currently no medical benefit claims assigned to their use. In general, PEMF is designed to support overall health and well-being in humans.

This website and the information featured, showcased, or otherwise appearing on it are not to be used as a substitute for medical advice, diagnosis, or treatment of any health condition or problem. Visitors to this website should not rely on the information provided for their own health problems. Any questions regarding your own health should be addressed to your own physician or other duly licensed healthcare provider.

This website makes no guarantees, warranties, or express or implied representations whatsoever with regard to the accuracy, completeness, timeliness, comparative or controversial nature, or usefulness of any information contained or referenced on this website.

The owners and operators of this website do not assume any risk whatsoever for your use of this website or the information posted herein. Health-related information and opinions change frequently, and therefore information contained on this website may be outdated, incomplete, or incorrect.

AURA Wellness is registered with the FDA as a medical device manufacturer and is certified to meet federal regulations 21 CFR 820, 21 CFR 803, and 21 CFR 806 under the MDSAP program.