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	2
HINGE HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Device Problem Information	7	7
Activation, Positioning or Separation Problem	4	4
Use of Device Problem	3	3
Use of Incorrect Control/Treatment Settings	2	2
Output above Specifications	1	1
Overheating of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	7	7
Headache	5	5
Unspecified Ear or Labyrinth Problem	3	3
Discomfort	3	3
Visual Impairment	3	3
Nausea	2	2
Dizziness	2	2
Cognitive Changes	2	2
Localized Skin Lesion	2	2
Burn(s)	2	2
Pain	2	2
Balance Problems	2	2
Dysphasia	1	1
Tingling	1	1
Electric Shock	1	1
Itching Sensation	1	1
Eye Irritation	1	1
Device Overstimulation of Tissue	1	1
Confusion/ Disorientation	1	1
Numbness	1	1
Reaction	1	1
Blurred Vision	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1