FDA Establishes Class II Status for Tongue Nerve Stimulators
December 19, 2025
December 19, 2025
WASHINGTON, Dec. 19 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued a final order to classify the electrical tongue nerve stimulator used to treat motor deficits as a class II device.
This action follows a De Novo classification request submitted by Helius Medical Inc., Newtown, Pennsylvania, for its portable neuromodulation stimulator (PoNS).
By placing this technology into class II, the FDA is establishing special contro . . .
This action follows a De Novo classification request submitted by Helius Medical Inc., Newtown, Pennsylvania, for its portable neuromodulation stimulator (PoNS).
By placing this technology into class II, the FDA is establishing special contro . . .