DeviceClearance

Product code SIG— Neurology

MeRT System

Classification name
Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)
Device class
Class 2
Regulation
21 CFR 882.5802
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

FDA classification definition

“External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields in brain areas outside cerebral cortex (e.g., cerebellum).”

— U.S. Food and Drug Administration, device classification record for product code SIG under 21 CFR 882.5802, via openFDA

Market context for product code SIG

FDA has cleared 1 device under product code SIG, 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 SIG

Recent clearances under product code SIG

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