TPLC - Total Product Life Cycle

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Device	stimulator, nerve, transcutaneous, for pain relief
Regulation Description	Transcutaneous electrical nerve stimulator for pain relief.
Product Code	GZJ
Regulation Number	882.5890
Device Class	2

Premarket Reviews
Manufacturer	Decision
BIOWAVE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
BOZHOU RONGJIAN MEDICAL APPLIANCE CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
DELTA INTERNATIONAL SERVICES & LOGISTICS S.R.L
	SUBSTANTIALLY EQUIVALENT	1
FAST TRACK TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
GIMER MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GONGGUAN TUTAMEN METALWORK CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
N & C HOLDINGS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ORIENTAL INSPIRATION LIMITED
	SUBSTANTIALLY EQUIVALENT	1
PIERENKEMPER GMBH
	SUBSTANTIALLY EQUIVALENT	1
SUBLIMED
	SUBSTANTIALLY EQUIVALENT	1
TENSCARE LTD
	SUBSTANTIALLY EQUIVALENT	1
TRUERELIEF
	SUBSTANTIALLY EQUIVALENT	1
WAT MEDICAL TECHNOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	1
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
ZYNEX MEDICAL OFFICER
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	26	26
Adverse Event Without Identified Device or Use Problem	9	9
Break	4	4
Patient Device Interaction Problem	4	4
Use of Device Problem	4	5
Patient-Device Incompatibility	3	3
Thermal Decomposition of Device	3	3
Improper or Incorrect Procedure or Method	3	3
Output Problem	2	2
Output above Specifications	2	2
Inappropriate/Inadequate Shock/Stimulation	2	2
Circuit Failure	1	1
Fire	1	1
Mechanical Problem	1	1
Energy Output Problem	1	1
Unintended Movement	1	2
Smoking	1	1
Defective Component	1	1
Defective Device	1	1
Positioning Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Battery Problem	1	1
Positioning Failure	1	1
Failure to Power Up	1	1
Charging Problem	1	1
Use of Incorrect Control/Treatment Settings	1	1
Product Quality Problem	1	1
Electromagnetic Interference	1	1
Inadequate or Insufficient Training	1	1
Human-Device Interface Problem	1	1
Electrical /Electronic Property Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	15	15
Burn(s)	13	13
Blister	9	9
Erythema	9	9
Pain	8	9
Electric Shock	5	5
Full thickness (Third Degree) Burn	5	5
Hypersensitivity/Allergic reaction	4	4
Itching Sensation	4	4
Burn, Thermal	4	4
Discomfort	4	4
Superficial (First Degree) Burn	3	3
Burning Sensation	3	3
Partial thickness (Second Degree) Burn	3	3
No Consequences Or Impact To Patient	3	3
Inadequate Pain Relief	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	3
Arrhythmia	2	2
Device Overstimulation of Tissue	2	2
Bruise/Contusion	2	2
Neuropathy	1	1
Failure of Implant	1	1
Nausea	1	1
Shock from Patient Lead(s)	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Muscle Stimulation	1	1
Muscular Rigidity	1	1
Vertigo	1	1
Numbness	1	1
Skin Inflammation	1	1
Fall	1	1
Scar Tissue	1	1
Reaction	1	1
Undesired Nerve Stimulation	1	1
Tissue Damage	1	1
Hypoesthesia	1	1
Increased Sensitivity	1	1
Skin Burning Sensation	1	2