Last synced on 1 March 2024 at 11:05 pm

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

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.

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

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.