QNO

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

Product code
QNO
Device name
Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
Device class
Class 2
21 CFR
21 CFR 872.5575
Medical specialty
Dental
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
3 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-05-16.

NumberDecision dateApplicantDevice nameSummary
K2403282024-05-16Signifier Medical Technologies, Ltd.eXciteOSA without remote control (3000); eXciteOSA w…PDF

1 summaries are archived here for direct download.

Official FDA classification page: QNO
Classification and pathway per current FDA publications. Data from openFDA (CC0).