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Indication — BrainsWay Deep TMS™ is indicated by the FDA for the treatment of depressive episodes in adult patients suffering from Major Depressive Disorder, who failed to achieve satisfactory improvement from previous anti-depressant medication treatment in the current episode. FDA 510(k) No. K122288 (Model 102), FDA 510(k) No. K173540 (Model 104), FDA 510(k) No. K210201, No. K203735 (Models 102 & 104).
Safety Information — Patients should consult with their doctor before undergoing BrainsWay Deep TMS. The most common side effects include headaches and application site pain or discomfort. There is also a very rare risk of seizure associated with the treatment. Patients with metal in or around the head as in metal plates, implants, and stents should not undergo Deep TMS treatment.