Enso for Migraine

Enso for Migraine is a wearable, app-controlled transcutaneous electrical nerve stimulation (TENS) device for patients 18 years or older. It treats migraines acutely and preventatively by delivering electrical stimulation through gel pads placed on the forehead to stimulate trigeminal nerve branches and reduce migraine severity and frequency.

Enso features a smaller neurostimulator (42×42×11 mm, 13.5g vs. 66×47×17 mm, 25g), a 3.85V battery, app-based controls with a single on-device button, a larger gel pad (86×49 mm vs. 94×20 mm) with lower current density (1.09 vs. 2.37 mA/cm²), and an asymmetrical biphasic waveform with passive recovery. Output parameters are similar with minor differences: max current 15 mA (vs. 16 mA) and max voltage up to 73V (vs. 60V).

IEC 60601, ISO 10993 (biocompatibility and electrical safety). The submission references finite element modeling studies comparing gel pad geometries and bench testing of therapeutic performance, gel pad interface characteristics, and human factors.

Enso and the predicate CEFALY Connected share identical indications for use and fundamental TENS mechanism. Technological differences (smaller form factor, larger gel pad, asymmetrical waveform, app-only controls) do not raise safety or effectiveness concerns. The larger pad lowers current density while maintaining comparable amplitude, and finite element modeling confirms negligible impact on induced current patterns to target nerves. Bench and human factors testing demonstrate equivalent safety and effectiveness.