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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea
Regulation Description 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.
Product CodeQNO
Regulation Number 872.5575
Device Class 2


Premarket Reviews
ManufacturerDecision
SIGNIFIER MEDICAL TECHNOLOGIES
  GRANTED 1
SIGNIFIER MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 3 3
2022 3 3
2023 3 3
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Device Markings/Labelling Problem 2 2
Melted 2 2
Thermal Decomposition of Device 1 1
Overheating of Device 1 1
Product Quality Problem 1 1
Temperature Problem 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Difficulty Chewing 1 1
Apnea 1 1
Fatigue 1 1
Dizziness 1 1
Pain 1 1
Tachycardia 1 1
Undesired Nerve Stimulation 1 1
Sensitivity of Teeth 1 1
Bruise/Contusion 1 1

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