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U.S. Department of Health and Human Services

Product Classification

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Device neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea
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
Product CodeQNO
Premarket Review Division of Dental and ENT Devices (DHT1B)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.5575
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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