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SIGClass II

Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)

21 CFR 882.5802 / Neurology

SIG is the FDA product code for Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd), a class II device type, regulated under 21 CFR 882.5802. FDA's definition for this code reads: "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)". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SIG
Device name
Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)
FDA 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).
Regulation
21 CFR 882.5802
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SIG

By decision year
1 clearance under product code SIG with a decision year between 2026 and 2026, 2026 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SIG by decision year
YearClearances
20261

Applicants with the most clearances

Product code SIG
Applicants holding the most 510(k) clearances under product code SIG
ApplicantClearances
Wave Neuroscience1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code SIG.