FDA Product Code QNO: Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
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.
Leading manufacturers include Signifier Medical Technologies, Ltd. and Signifier Medical Technologies.
FDA 510(k) Cleared Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea Devices (Product Code QNO)
About Product Code QNO - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QNO since 2021, with 2 receiving FDA clearance (average review time: 161 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
QNO devices are reviewed by the Dental panel. Browse all Dental devices →