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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cranial electrotherapy stimulator to treat insomnia and/or anxiety
Definition To provide electrical current to the head to treat insomnia and/or anxiety
Product CodeQJQ
Regulation Number 882.5800
Device Class 2


Premarket Reviews
ManufacturerDecision
INNOVATIVE NEUROLOGICAL DEVICES LLC
  SUBSTANTIALLY EQUIVALENT 1
NEUROVALENS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NEUROVALENS LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 30 30
Patient Device Interaction Problem 30 30
Defective Component 8 8
Defective Device 8 8
Burst Container or Vessel 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Tinnitus 10 10
Superficial (First Degree) Burn 9 9
Headache 6 6
Memory Loss/Impairment 4 4
Twitching 2 2
Unspecified Eye / Vision Problem 2 2
Atrial Flutter 2 2
Neuropathy 1 1
Arrhythmia 1 1
Stroke/CVA 1 1
Electric Shock 1 1
Emotional Changes 1 1
Dizziness 1 1
Overwear Syndrome 1 1
Atrial Fibrillation 1 1
Cognitive Changes 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Chest Pain 1 1
Vomiting 1 1
Loss of Range of Motion 1 1
Visual Impairment 1 1
Bradycardia 1 1
Bruxism 1 1
Convulsion/Seizure 1 1
Blurred Vision 1 1
Joint Contracture 1 1
Irritability 1 1
Dementia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Fisher Wallace Laboratories Inc. II May-17-2023
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