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 R20, R30, R30 with MagOption, X100, and X100 with MagOption are all FDA 510(k) cleared (k160280, k061645, k091940 and k150641).
k150641: The intended use is
treatment of Major Depressive Disorder in adult patients who have failed to receive
satisfactory improvement from prior antidepressant medication in the current
k160280, k061645, k091940: The intented use is for 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 (except the above cleared intended use). For further information please contact MagVenture
2300 Lakeview Parkway,
Alpharetta, GA 30009
Phone: +1 888-MAGPRO-4
Fax: +1 678-809-1415