QNO

3 FDA 510(k) clearances · Product code

FDA profile

Official device name

Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea

Device class

Class II (moderate risk)

Regulation

21 CFR 872.5575

Medical specialty

Dental

FDA definition

A neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea consists of a removable intraoral mouthpiece that uses electrodes to deliver neuromuscular stimulation to the tongue to strengthen tongue musculature to reduce snoring and obstructive sleep apnea.

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free