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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sleep appliances with patient monitoring
Regulation Description Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
Definition For the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy.
Product CodePLC
Regulation Number 872.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
PROSOMNUS SLEEP TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
SOMNOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Sleep Dysfunction 1 1
Weight Changes 1 1

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