TPLC - Total Product Life Cycle

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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	3
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Use of Device Problem	4	4
Patient-Device Incompatibility	3	3
Insufficient Information	3	3
Activation, Positioning or Separation Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Use of Incorrect Control/Treatment Settings	2	2
Product Quality Problem	2	2
Overheating of Device	2	2
Wireless Communication Problem	1	1
Output above Specifications	1	1
Thermal Decomposition of Device	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
Headache	7	7
Insufficient Information	5	5
Pain	4	4
Visual Impairment	4	4
Unspecified Ear or Labyrinth Problem	3	3
Discomfort	3	3
Blurred Vision	3	3
Nausea	2	2
Dizziness	2	2
Cognitive Changes	2	2
Balance Problems	2	2
Dysphasia	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Halo	1	1
Tingling	1	1
Electric Shock	1	1
Burn, Thermal	1	1
No Known Impact Or Consequence To Patient	1	1
Confusion/ Disorientation	1	1
Device Overstimulation of Tissue	1	1
Visual Disturbances	1	1
Numbness	1	1
Reaction	1	1
Vitreous Floaters	1	1