FDA product code SIG: Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)
SIG is the FDA product code for transcranial magnetic stimulation system for post traumatic stress disorder (ptsd). It is a Class II device, regulated under 21 CFR 882.5802 and reviewed by the Neurology panel. Devices under SIG reach the market by 510(k); FDA lists no cleared 510(k)s for it.
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).
Classification
| Field | Value |
|---|---|
| Device name | Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd) |
| Device class | Class II |
| Regulation | 21 CFR 882.5802 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
Recalls for SIG devices
openFDA lists no recalls for product code SIG.
Frequently asked questions
What is FDA product code SIG?
SIG is the FDA product code for transcranial magnetic stimulation system for post traumatic stress disorder (ptsd). It is a Class II device, regulated under 21 CFR 882.5802 and reviewed by the Neurology panel.
What device class is SIG?
Class II, regulation 21 CFR 882.5802. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SIG
- Run a recall and safety report across every SIG manufacturer
- Watch product code SIG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.