United States federal law regulates the sale of Medical Devices. The US Food and Drug Administration (FDA) grants clearance to manufacturers to market devices for specific indications, after safety and efficacy have been demonstrated, by issuance of either 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 MagPro devices for other than FDA cleared intended uses is considered investigational. In accordance with US federal regulations, an IDE and/or IRB approval may be required for use of MagPro devices for uses distinct from the FDA cleared Indication(s) for Use. The sponsor is responsible for obtaining appropriate, required approvals. please consult FDA's website (www.fda.gov) for more information.
For further information please contact:
2300 Lakeview Parkway, Suite 700
Alpharetta GA 30009
Phone: +1 888-MAGPRO-4 (+1 888 624 7764)
Fax: +1 678-809-1415