The product Accurate®, which is marketed as non-pharmacological assistive diagnosis and assistive treatment for mental health and cognitive conditions by its manufacturer, has been deemed a Consumer Product which means it is not a licensed for medical device, drug or natural health product.
This means that consumers can only make non-therapeutic claims about this in their advertising campaigns and Immense technologies stresses they will never imply diagnosis or treatment of any kind with our ads.
Determination on Accurate® as a general wellness product is based on the following information: (i) the intended use of the product is for passive brain training for personal enrichment; (ii) noninvasively records brain activity to provide a brief interruption and change in the media playing through the screen and headphone. Therefore, FDA does not intend to enforce any applicable regulatory requirements under the Act, including premarket notification, and its implementing regulations for the Accurate®.