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- QNONeuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea2Product Code
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Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
- Page Type
- Product Code
- 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.
- Physical State
- The device is an intraoral removable mouthpiece that delivers a series of electrical pulse bursts with rest periods to electrodes that sandwich the tongue
- Technical Method
- The device is an external tongue muscle stimulator that delivers neuromuscular electrical stimulation to intrinsic and extrinsic tongue muscles in the daytime in order to increase muscle tone and prevent excess tongue muscle relaxation during sleep.
- Target Area
- The device is placed in the mouth but specifically targets the musculature of the tongue
- Regulation Medical Specialty
- Dental
- Review Panel
- Dental
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 872.5575
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
Product code QNO is linked to regulation 21CFR872.5575, which does not seem to exist yet. It may be pending at the moment.