| 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 Code | QNO |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
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
|
|---|
| Recognized Consensus Standard
|
| Third Party Review |
Not Third Party Eligible |
