BCIwiki (bciwiki.com) — Naox Technologies Sas received an FDA 510(k) decision of Substantially Equivalent for NX01 (NX01) on November 25, 2025, under submission number K251550. The submission followed the Traditional 510(k) clearance pathway.
FDA lists the product under the device classification name Reduced- Montage Standard Electroencephalograph. It is a Class 2 device under regulation number 882.1400, assigned to the Neurology advisory committee. Reduced-montage systems record with fewer electrodes than a conventional clinical montage, trading spatial resolution for faster setup and the possibility of wearable form factors.