TPLC - Total Product Life Cycle

• Device: stimulator, nerve, electrical, transcutaneous, for migraine
• Regulation Description: Transcutaneous electrical nerve stimulator to treat headache.
• 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	3
NEUROLIEF LTD.
	SUBSTANTIALLY EQUIVALENT	2
NU EYNE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SOTERIX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
WAT MEDICAL TECHNOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	1
YBRAIN, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	1	1
2021	7	7
2023	2	2
2024	6	6
2025	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	3	3
Activation, Positioning or Separation Problem	2	2
Patient-Device Incompatibility	2	2
Therapeutic or Diagnostic Output Failure	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
Output above Specifications	1	1
Charging Problem	1	1
Material Separation	1	1
Power Problem	1	1
Appropriate Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	5	5
Headache	5	5
Unspecified Ear or Labyrinth Problem	3	3
Visual Impairment	3	3
Nausea	2	2
Dizziness	2	2
Cognitive Changes	2	2
Pain	2	2
Balance Problems	2	2
Dysphasia	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Tingling	1	1
Electric Shock	1	1
Device Overstimulation of Tissue	1	1
Confusion/ Disorientation	1	1
No Known Impact Or Consequence To Patient	1	1
Discomfort	1	1
Numbness	1	1
Reaction	1	1
Blurred Vision	1	1