Currently, AURA Wellness is 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 approval of our facility or our devices.
Aura devices are to be used as massage like instruments, there is no medical benefit claim currently 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 is not to be used as a substitute for medical advice, diagnosis or treatment of any health condition or problem. Those who visit this web site should not rely on information provided on it for their own health problems. Any questions regarding your own health should be addressed to your 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 Web site. This website and its owners and operators 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 Health-related information and opinions change frequently and therefore information contained on this Website may be outdated, incomplete or incorrect.
FDA Establishment Registration & Device Listing
Proprietary Name: NOVA HD
Classification Name: MASSAGER, THERAPEUTIC, ELECTRIC
Product Code: ISA6
Device Class: 1
Regulation Number: 890.5660 7
Medical Specialty: Physical Medicine
Registered Establishment Name: Aura Wellness LLC
Registered Establishment Number: 3018608545
Owner/Operator: Aura Wellness , LLC
Owner/Operator Number: 10081462
Established Operations: Manufacturer