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U.S. Department of Health and Human Services

Product Classification

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Device device for sleep apnea testing based on mandibular movement
Definition A device for sleep apnea testing based on mandibular movement is a prescription device intended to aid in evaluation of sleep apnea during sleep in patients suspected of having sleep breathing disorders by analyzing sensor readings of mandibular movement. The device is not intended as a substitute for full polysomnography nor intended to be used as an apnea monitor.
Physical State The device includes a cloud-based software that analyzes data from the sensor placed on the patient’s mandible. By analyzing patient’s mandibular movements, the device detects obstructive respiratory disturbances and provides notifications about the severity of obstructive sleep apnea.
Technical Method The principle of operation is based on analyzing the mandibular movement signals recorded by the device.
Target Area Mandible.
Regulation Medical Specialty Ear Nose & Throat
Review Panel Anesthesiology
Product CodeQRS
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.2376
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible