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TPLC
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Device
stimulator, nerve, electrical, transcutaneous, for migraine
Definition
Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.
Product Code
PCC
Regulation Number
882.5891
Device Class
2
Premarket Reviews
Manufacturer
Decision
CEFALY TECHNOLOGY
SUBSTANTIALLY EQUIVALENT
6
NEUROLIEF LTD.
SUBSTANTIALLY EQUIVALENT
2
NU EYNE CO., LTD
SUBSTANTIALLY EQUIVALENT
1
NU EYNE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SOTERIX MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
STX-MED SPRL
GRANTED
1
WAT MEDICAL TECHNOLOGY (NINGBO) CO., LTD
SUBSTANTIALLY EQUIVALENT
1
WAT MEDICAL TECHNOLOGY INC.
SUBSTANTIALLY EQUIVALENT
1
YBRAIN, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
2
2
2016
2
2
2017
2
2
2019
2
2
2020
1
1
2021
7
7
2023
2
2
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
5
5
Patient-Device Incompatibility
3
3
Activation, Positioning or Separation Problem
2
2
Use of Device Problem
2
2
Use of Incorrect Control/Treatment Settings
2
2
Product Quality Problem
2
2
Wireless Communication Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Human Factors Issue
1
1
Thermal Decomposition of Device
1
1
Charging Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Device Operates Differently Than Expected
1
1
Power Problem
1
1
Appropriate Term/Code Not Available
1
1
Unexpected Therapeutic Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Headache
8
8
Insufficient Information
4
4
Pain
4
4
Visual Impairment
4
4
Dizziness
3
3
Unspecified Ear or Labyrinth Problem
3
3
Reaction
3
3
Blurred Vision
3
3
Nausea
2
2
Cognitive Changes
2
2
No Known Impact Or Consequence To Patient
2
2
Balance Problems
2
2
Dysphasia
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Tingling
1
1
Halo
1
1
Electric Shock
1
1
Burn, Thermal
1
1
Confusion/ Disorientation
1
1
Visual Disturbances
1
1
Weakness
1
1
Numbness
1
1
Vitreous Floaters
1
1
Therapeutic Response, Decreased
1
1
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