Our TMS product family (Apollo and PowerMAG) are class IIa medical devices and are certified by the notified body SLG with the identifier CE 0494.
FDA Clearance (United States)
The Apollo TMS Therapy System is 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 (K180313).
Investigational Devices: The use of the Apollo TMS Therapy System for other than their FDA cleared intended uses and the use of all other products on this website is considered as investigational. Such use is only permitted if the Investigational Device Exemption (IDE) guidelines of the FDA have been followed. For full information on the IDE procedure, please consult FDA’s websitewww.fda.gov