Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
QNO · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.5575
Classification
FDA Product Code
QNO
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 872.5575
Review panel
DE
Medical specialty
Dental
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.