DeviceClearance

Product code SHX— Neurology

Modius Spero

Classification name
Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms
Device class
Class 2
Regulation
21 CFR 882.5807
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

FDA classification definition

“A transcranial nerve stimulation device for the treatment of post-traumatic stress disorder (PTSD) associated symptoms is a prescription, home-use, externally worn device that applies electrical stimulation to a location on the patient’s head. The device is not intended as a stand-alone therapy or to alter usual care treatment.”

— U.S. Food and Drug Administration, device classification record for product code SHX under 21 CFR 882.5807, via openFDA

Market context for product code SHX

FDA has cleared 1 device under product code SHX, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SHX

Recent clearances under product code SHX

Data sourced from openFDA. This site is unofficial and independent of the FDA.