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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
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
BRAINSWAY LTD.
  SUBSTANTIALLY EQUIVALENT 1
BRAINWAYS LTD.
  GRANTED 1
BTL INDUSTRIES INC.
  SUBSTANTIALLY EQUIVALENT 1
NEURONETICS
  SUBSTANTIALLY EQUIVALENT 1
NEURONETICS, INC
  SUBSTANTIALLY EQUIVALENT 1
TELEEMG, LLC
  SUBSTANTIALLY EQUIVALENT 2
TONICA ELEKTRONIK A/S
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2021 5 5
2022 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Patient-Device Incompatibility 2 2
Insufficient Information 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
Anxiety 3 3
Emotional Changes 2 2
Headache 2 2
Memory Loss/Impairment 2 2
Convulsion/Seizure 2 2
Speech Disorder 1 1
Dysgeusia 1 1
Suicidal Ideation 1 1
Eye Pain 1 1
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Nausea 1 1
Pain 1 1
Tachycardia 1 1
Shaking/Tremors 1 1
Cognitive Changes 1 1
Confusion/ Disorientation 1 1
No Code Available 1 1

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