QNO — Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea Class II

FDA Device Classification

Classification Details

Product Code
QNO
Device Class
Class II
Regulation Number
872.5575
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240328signifier medical technologieseXciteOSA without remote control (3000); eXciteOSA with remote control (6000)May 16, 2024
K223446signifier medical technologieseXciteOSA without remote control (3000); eXciteOSA with remote control (6000)January 18, 2023
DEN200018signifier medical technologieseXciteOSA with remote and eXciteOSA without remoteFebruary 5, 2021