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Regulations in the United States

*United States Federal Law regulates the sale of Medical Devices. The Blossom TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients, who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. (K220625) All other devices on this website are not approved and/or cleared for use in treatment and/or diagnosis in the United States. All investigational devices must be labeled in accordance with the labeling requirements of the IDE regulation (§ 812.5) and bear a label that states:
“CAUTION.
Investigational Device. Restricted by federal (or United States) law to research use.”

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