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.
FDA cleared for treatment of Major Depressive Disorder
MagPro® stimulators R20, R30, R30 with MagOption, X100, and X100 with MagOption are all FDA 510(k) cleared for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode (k170114 and k150641).
FDA cleared for stimulation of peripheral nerves for diagnostic purposes
MagPro® stimulators R20, R30, R30 with MagOption, X100, and X100 with MagOption are all FDA 510(k) cleared for stimulation of peripheral nerves for diagnostic purposes (k160280, k061645, k091940)
The use of the devices for other than their FDA cleared intended uses 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."
For further information please contact MagVenture.
2300 Lakeview Parkway, Suite 700
Alpharetta GA 30009
Phone: +1 888-MAGPRO-4 (+1 888 624 7764)
Fax: +1 678-809-1415