QNOClass II
Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
Dental · 21 CFR 872.5575
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.
MDR events10All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances3All time
Recent MDR events
10 adverse event reports on file
- EXCITEOSAJan 30, 2025InjurySignifier Medical Technologies LimitedMW5165450
- EXCITEOSADec 22, 2023InjurySignifier Medical Technologies3017737771-2023-00028
- EXCITEOSAJul 28, 2023InjurySignifier Medical Technologies3017737771-2023-00033
- EXCITEOSAJun 28, 2023MalfunctionUnknownMW5118989
- EXCITEOSANov 6, 2022InjurySignifier Medical Technologies3017737771-2022-00021
- EXCITEOSAMar 21, 2022InjurySignifier Medical Technologies3017737771-2022-00011
- SIGNIFIER MEDICAL EXCITE OSAMar 11, 2022MalfunctionSignifier Medical Technologies LimitedMW5108111
- EXCITEOSAJun 28, 2021MalfunctionSignifier Medical Technologies Ltd3017737771-2021-00001
- EXCITEOSAJun 3, 2021MalfunctionSignifier Medical Technologies Ltd3017737771-2021-00000
- EXCITEOSAMay 14, 2021Signifier Medical Technologies LlcMW5101367
Event type breakdown
Injury5
Malfunction4
Unspecified1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
6 firms currently registered for this product code
510(k) clearances
3 clearances for this product code
- Signifier Medical Technologies, Ltd.May 16, 2024
K240328 · eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
- Signifier Medical Technologies, Ltd.Jan 18, 2023
K223446 · eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
- Signifier Medical TechnologiesFeb 5, 2021
DEN200018 · eXciteOSA with remote and eXciteOSA without remote