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®.