Regulations in the USA In the USA federal law regulates the sale of Medical Devices through the US Food and Drug Administration (FDA). This is done to ensure safety and effectiveness. Devices which are permitted to be marketed for their intended use must either have a 510(k) or PMA clearance. MagPro® stimulators R30, R30 with MagOption, X100, and X100 with MagOption are all FDA 510(k) cleared (k061645, k091940).  The intended use is stimulation of peripheral nerves for diagnostic purposes. The use of devices for other than their FDA cleared intended use is considered as investigational. Such use is only permitted if the Investigational Device Exemption (IDE) guidelines have been followed. For full information on this procedure, please consult FDA's website (www.fda.gov).  All investigational devices must be labeled in accordance with the labeling provisions of the IDE regulation (§ 812.5) and must bear a label with this statement:  "CAUTION Investigational Device. Limited by Federal (or United States) law to investigational use." Please note that transcranial magnetic stimulation ( TMS, rTMS) with MagPro stimulators  is considered investigational in the USA. For further information please contact MagVenture®: MagVenture, Inc. 303 Perimeter Center North, Suite 300 Atlanta GA 30346 Phone: +1 888-MAGPRO-4 Fax: +1 678-809-1415 Email: infousa@magventure.com www.magventure.com