TPLC - Total Product Life Cycle

• Device: device, iontophoresis, other uses
• Product Code: EGJ
• Regulation Number: 890.5525
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ACCLARENT, INC.
	SUBSTANTIALLY EQUIVALENT	2
ACTIVATEK INC.
	SUBSTANTIALLY EQUIVALENT	2
DERMADRY LABORATORIES INC.
	SUBSTANTIALLY EQUIVALENT	1
HIDREX GMBH
	SUBSTANTIALLY EQUIVALENT	1
HIGHTECH DEVELOPMENT
	SUBSTANTIALLY EQUIVALENT	1
MICROLAB AMERICAS INC
	SUBSTANTIALLY EQUIVALENT	1
SAALMANN MEDICAL GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
SOTERIX MEDICAL,INC.
	SUBSTANTIALLY EQUIVALENT	1
TOP-RANK HEALTH CARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	1	1
2015	2	2
2016	3	3
2017	3	3
2018	8	8
2019	2	2
2020	2	2
2022	1	1
2023	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient-Device Incompatibility	7	7
Adverse Event Without Identified Device or Use Problem	5	5
Insufficient Information	5	5
Temperature Problem	1	1
Device Operates Differently Than Expected	1	1
Material Protrusion/Extrusion	1	1
Component Incompatible	1	1
Overheating of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Skin Irritation	8	8
Full thickness (Third Degree) Burn	5	5
Burn, Thermal	3	3
Burn(s)	3	3
Dizziness	2	2
Partial thickness (Second Degree) Burn	2	2
Viral Infection	1	1
Discomfort	1	1
Malaise	1	1
Numbness	1	1
Post Traumatic Wound Infection	1	1
Sleep Dysfunction	1	1
Fatigue	1	1
Pain	1	1
Rash	1	1
Skin Discoloration	1	1
Cognitive Changes	1	1
Tinnitus	1	1
Convulsion/Seizure	1	1
Epilepsy	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Blister	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Hidrex GmbH	III	Feb-22-2017
2	Tapemark Company	III	Jan-05-2022