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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nystagmograph
Product CodeGWN
Regulation Number 882.1460
Device Class 2


Premarket Reviews
ManufacturerDecision
INTERACOUSTICS A/S
  SUBSTANTIALLY EQUIVALENT 1
NEUROBIT TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEUROLIGN USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
VESTIBULAR FIRST
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 5 5
2021 1 1
2022 1 1
2023 3 3
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 4 4
Adverse Event Without Identified Device or Use Problem 2 2
Output Problem 1 1
Break 1 1
False Positive Result 1 1
Fracture 1 1
Failure to Power Up 1 1
Defective Device 1 1
Communication or Transmission Problem 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Not Applicable 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Skin Inflammation/ Irritation 1 1
Head Injury 1 1
Hearing Impairment 1 1
Pain 1 1
Visual Impairment 1 1
No Known Impact Or Consequence To Patient 1 1

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