Innovative Measurement of Physiological Function
Our new general wellness, low-risk device consists of an image scanner, proprietary software, and computer which requires an internet connection. The product provides objective measurements of evoked electrophysiological responses that provide information on the electrophysiological function of the six primary organs and systems within the body. This product is not a diagnostic medical device.
This low-risk device meets the FDA Guidance of a General Wellness, Low Risk Device and can bring significant value to the quest for better health.
a. Does the product’s intended use and claims refer to sustaining or offering general improvement to conditions and functions associated with a general state of health: weight management, physical fitness, relaxation or stress management, mental activity, self-esteem, including personal appearance, sleep management, or sexual function?
b. Does the product’s intended use include a claim relating to a disease or medical condition?
c. Is the disease or medical condition a chronic one for which it is well understood that healthy lifestyle choices may play a part in helping to reduce its risk or impact, as discussed in this guidance?
d. Does the claim use language that the product may help to reduce the risk of, or may help living well with, a chronic disease or condition, as discussed in this guidance?
Is the product invasive, involve an intervention or technology that would pose a risk to the user’s safety if device controls are not applied, such as risks from lasers, radiation exposure, implantation procedures, raise novel question of usability, or raise questions of biocompatibility? In answering this question, consider whether CDRH actively regulates products of the same type as the product in question.