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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, anti-snoring
Regulation Description Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
Product CodeLRK
Regulation Number 872.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
AIRWAY MANAGEMENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALLEN J. MOSES, DDS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN SLEEP DENTISTRY
  SUBSTANTIALLY EQUIVALENT 1
APNEA SCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BLUESOM
  SUBSTANTIALLY EQUIVALENT 1
COMFORT ACRYLICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FIRMA INGEMARSSON
  SUBSTANTIALLY EQUIVALENT 1
FUSELIER ENTERPRISES, LLC
  SUBSTANTIALLY EQUIVALENT 1
GERGENS ORTHODONTIC LAB
  SUBSTANTIALLY EQUIVALENT 1
INSERT MOLDING SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OVENTUS MANUFACTURING PTY LTD
  SUBSTANTIALLY EQUIVALENT 4
PRISMATIK
  SUBSTANTIALLY EQUIVALENT 1
SICAT GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
SLEEP SCIENCE PARTNERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOMNOMED INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2015 28 28
2016 18 18
2017 32 32
2018 61 61
2019 56 56
2020 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 87 87
Break 29 29
Detachment Of Device Component 16 16
Detachment of Device or Device Component 10 10
Material Separation 9 9
Crack 9 9
Patient-Device Incompatibility 9 9
Material Fragmentation 5 5
Extrusion 5 5
Loose or Intermittent Connection 5 5
Fitting Problem 5 5
Component Falling 4 4
Device Subassembly 4 4
Material Integrity Problem 4 4
Device Operates Differently Than Expected 4 4
Insufficient Information 4 4
Material Split, Cut or Torn 4 4
Device Fell 3 3
Unintended Movement 2 2
Defective Component 2 2
Malposition of Device 2 2
Product Quality Problem 2 2
Difficult to Remove 2 2
Patient Device Interaction Problem 2 2
Fracture 2 2
Screw 2 2
Bent 1 1
Device Reprocessing Problem 1 1
Collapse 1 1
Migration or Expulsion of Device 1 1
Device Dislodged or Dislocated 1 1
Material Protrusion/Extrusion 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Slipped 1 1
Stretched 1 1
Use of Device Problem 1 1
Failure to Align 1 1
Split 1 1
Device Handling Problem 1 1
Deformation Due to Compressive Stress 1 1
Device Appears to Trigger Rejection 1 1
Inadequacy of Device Shape and/or Size 1 1
Improper or Incorrect Procedure or Method 1 1
Chemical Problem 1 1
Corroded 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 57 57
Reaction 55 55
Swelling 24 24
Pain 17 17
Discomfort 14 14
No Information 14 14
Rash 10 10
Erythema 10 10
Irritation 9 9
Inflammation 7 7
No Code Available 7 7
Burning Sensation 6 6
Hypersensitivity/Allergic reaction 6 6
Foreign Body In Patient 5 5
Tingling 4 4
Unspecified Infection 4 4
Itching Sensation 3 3
Tooth Fracture 3 3
Post Operative Wound Infection 3 3
Tissue Damage 3 3
Peeling 3 3
No Consequences Or Impact To Patient 3 3
Joint Dislocation 3 3
Numbness 2 2
Sensitivity of Teeth 2 2
Sleep Dysfunction 2 2
Failure of Implant 2 2
Aspiration/Inhalation 2 2
Erosion 2 2
Choking 2 2
Chemical Exposure 1 1
No Patient Involvement 1 1
Complaint, Ill-Defined 1 1
Joint Disorder 1 1
Chest Tightness/Pressure 1 1
Bronchitis 1 1
Diarrhea 1 1
Anxiety 1 1
Scar Tissue 1 1
Patient Problem/Medical Problem 1 1
Radiation Exposure, Unintended 1 1
Device Embedded In Tissue or Plaque 1 1
Burn(s) 1 1
Fever 1 1
Wheal(s) 1 1
Ulcer 1 1
Pressure Sores 1 1
Toxicity 1 1
Therapeutic Effects, Unexpected 1 1
Ulceration 1 1
Partial thickness (Second Degree) Burn 1 1
Neck Pain 1 1
Low Oxygen Saturation 1 1
Fungal Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Respire Medical II May-29-2018
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