TPLC - Total Product Life Cycle

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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	5
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
STX-MED SPRL
	GRANTED	1
WAT MEDICAL TECHNOLOGY (NINGBO) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
WAT MEDICAL TECHNOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient-Device Incompatibility	3	3
Insufficient Information	3	3
Use of Incorrect Control/Treatment Settings	2	2
Product Quality Problem	2	2
Use of Device Problem	2	2
Activation, Positioning or Separation Problem	2	2
Device Operates Differently Than Expected	1	1
Human Factors Issue	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Power Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Thermal Decomposition of Device	1	1
Unexpected Therapeutic Results	1	1
Appropriate Term/Code Not Available	1	1
Wireless Communication Problem	1	1
Charging Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Headache	8	8
Pain	4	4
Visual Impairment	4	4
Blurred Vision	3	3
Dizziness	3	3
Reaction	3	3
Unspecified Ear or Labyrinth Problem	3	3
Insufficient Information	2	2
No Known Impact Or Consequence To Patient	2	2
Balance Problems	2	2
Cognitive Changes	2	2
Nausea	2	2
Visual Disturbances	1	1
Weakness	1	1
Tingling	1	1
Confusion/ Disorientation	1	1
Electric Shock	1	1
Numbness	1	1
Burn, Thermal	1	1
Dysphasia	1	1
Halo	1	1
Therapeutic Response, Decreased	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Vitreous Floaters	1	1