Unsere TMS Produktfamilie (Apollo und PowerMAG) sind Medizinprodukte der Klasse IIa und durch die Benannte Stelle SLG mit der Kennziffer CE 0494 zertifiziert.
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