21 CFR 882.5807 — Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms

Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5807

Identification

Modius Spero is a prescription, home-use, externally worn device that applies electrical stimulation to a location on the patient's head. It is indicated for the treatment of symptoms associated with post-traumatic stress disorder (PTSD) for use in conjunction with a comprehensive treatment plan under the direction of a healthcare professional, in adults aged 22 and older. The device is not intended as a stand-alone therapy or to alter usual care treatment.

Classification Rationale

FDA has determined that the device can be classified in class II with the establishment of special controls for class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.

Product Codes