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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transcranial magnetic stimulation system for obsessive-compulsive disorder
Regulation Description Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
Definition External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum).
Product CodeQCI
Regulation Number 882.5802
Device Class 2


Premarket Reviews
ManufacturerDecision
BRAIN ULTIMATE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BTL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEURONETICS
  SUBSTANTIALLY EQUIVALENT 1
NEURONETICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEEMG, LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 5 6
2022 2 2
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 2 2
Insufficient Information 2 3
Adverse Event Without Identified Device or Use Problem 2 2
Malposition of Device 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Headache 3 3
Emotional Changes 2 2
Memory Loss/Impairment 2 2
Anxiety 2 2
Convulsion/Seizure 2 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Speech Disorder 1 1
Nausea 1 1
Cognitive Changes 1 1
Confusion/ Disorientation 1 1
Suicidal Ideation 1 1
Pain 1 1
Swelling/ Edema 1 1
Tachycardia 1 1
Shaking/Tremors 1 1
Dysgeusia 1 1
Eye Pain 1 1

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