DeviceClearance

Product code QNO— Dental

eXciteOSA with remote and eXciteOSA without remote

Classification name
Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
Device class
Class 2
Regulation
21 CFR 872.5575
Advisory panel
Dental
Total cleared
3
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QNO under 21 CFR 872.5575, via openFDA

Market context for product code QNO

FDA has cleared 3 devices under product code QNO between 2021 and 2024, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QNO

Recent clearances under product code QNO

Data sourced from openFDA. This site is unofficial and independent of the FDA.