The United States Food and Drug Administration (FDA) determines and regulates the status and classification of all medical devices that are sold in the United States. Individuals and companies cannot, of themselves, determine if their device is medical or non-medical, nor can they decide what classification, if any, a device falls into. our current line of GSR (Galvanic Skin Response) devices are regulated and fall into a Class IIa medical category. It was necessary for us to apply for and be granted an FDA 510 (K) market clearance. This allows us to market our devices, with certain restrictions, here in the US. Our 510 (K) is only the first step. There are many other requirements we and any manufacturer, must continually meet.