Neurology · 510(k) · 2026
MeRT System
Wave Neuroscience. Cleared by FDA on 3 June 2026 under submission K260402, product code SIG (transcranial magnetic stimulation system for post traumatic stress disorder (ptsd)). What FDA's record says, in FDA's words.
Device record · K260402
- Device. MeRT SystemDEVICE
- Company. Wave NeuroscienceCOMPANY
- Decision. 3 June 2026, 510(k), substantially equivalent (traditional review); received 6 February 2026DECISION
- Panel. NeurologyPANEL
- Product code. SIG, Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)CODE
- Regulation. 21 CFR 882.5802, Class IIREG
- Source. FDA database entry · decision document (14 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
, post -traumatic stress disorder (“PTSD”) is a neurological and psychiatric disorder or condition, as is obsessive compulsive disorder (“OCD”) associated with the predicate device’s indications for use. There is extensive evidence of similar underlying neurophysiological mechanisms of action in the two disorders, suggesting the potential for similar response to neuromodulation. The differences in design and indications for use when comparing the MeRT System and the cited predi cate are not significant and do not result in differing questions of safety and effectiveness. As can be seen in the table below, the identical performance specifications can be found in the TMS Stimulator, coils for motor threshold determination and treatment coil, power source, pulse type, pulse width, cooling, max coil temperature, peak magnetic field strength, peak magnetic field gradient. Differences in
The product code's definition, from FDA's classification record. 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).
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsnone of the tracked terms matched
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1 report filed against devices carrying product code SIG. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Injury · Magventure rTMS · report MW6003227
I received rtms(REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION) from (b)(6) starting in (b)(6) starting on (b)(6) 2025, ending on (b)(6) 2025. While receiving tms i informed them that I was experiencing adverse side-effects, including pain behind my eye, negative thoughts, bad memories, anxiety, panic and was told it was a part of the procedure. They adjusted the machine several times during my treatment and never noted it on myreports, along with my complaints. I was switched clinics to the […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SIG, in Neurology, or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.