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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
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
GERGEN'S ORTHODONTIC LAB
  SUBSTANTIALLY EQUIVALENT 1
MARK ABRAMSON, D.D.S., INC
  SUBSTANTIALLY EQUIVALENT 1
PROSOMNOUS SLEEP TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
RESIDENTIAL HOME SLEEP SERVICES
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 1 1
Skin Irritation 1 1
Burning Sensation 1 1
Sleep Dysfunction 1 1

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