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QNOClass II

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

21 CFR 872.5575 / Dental

QNO is the FDA product code for Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea, a class II device type, regulated under 21 CFR 872.5575. FDA's definition for this code reads: "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". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QNO
Device name
Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
FDA 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.
Regulation
21 CFR 872.5575
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code QNO

By decision year
3 clearances under product code QNO with a decision year between 2021 and 2024, 2021 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QNO by decision year
YearClearances
20211
20231
20241

Applicants with the most clearances

Product code QNO
Applicants holding the most 510(k) clearances under product code QNO
ApplicantClearances
Signifier Medical Technologies Limited3

Companies listing this code with FDA

Companies whose registered establishments list this code