TPLC - Total Product Life Cycle

• Device: media, electroconductive
• Product Code: GYB
• Regulation Number: 882.1275
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
GUANGZHOU XINBO ELECTRONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NIHON KOHDEN CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
PREMIER NORTH AMERICA INC.
	SUBSTANTIALLY EQUIVALENT	1
SOMNOMEDICS GMBH
	SUBSTANTIALLY EQUIVALENT	1
SPES MEDICA S.R.L
	SUBSTANTIALLY EQUIVALENT	1
SPES MEDICA S.R.L.
	SUBSTANTIALLY EQUIVALENT	2
TONE-A-MATIC INTERNATIONAL INC.
	SUBSTANTIALLY EQUIVALENT	1
TOP-RANK HEALTH CARE CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
WUHAN GREENTEK PTY LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	2	2
2019	3	3
2020	2	2
2021	4	4
2022	4	4
2023	6	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	6	6
Patient Device Interaction Problem	4	4
Patient-Device Incompatibility	3	3
Human-Device Interface Problem	2	2
Use of Device Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Inadequate User Interface	1	1
Incomplete or Inadequate Connection	1	1
Output Problem	1	1
Insufficient Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Skin Irritation	4	4
Hypersensitivity/Allergic reaction	2	2
Itching Sensation	2	2
Corneal Abrasion	2	2
Partial thickness (Second Degree) Burn	2	2
Full thickness (Third Degree) Burn	2	2
Eye Pain	2	2
Insufficient Information	2	2
No Clinical Signs, Symptoms or Conditions	1	1
Skin Inflammation/ Irritation	1	1
Unspecified Tissue Injury	1	1
Convulsion/Seizure	1	1
Hair Loss	1	1
Nausea	1	1
Pain	1	1
Rash	1	1
Local Reaction	1	1
Skin Erosion	1	1
Swelling	1	1
Burning Sensation	1	1
Discomfort	1	1
Malaise	1	1
Skin Inflammation	1	1
Superficial (First Degree) Burn	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	National Distribution & Contracting Inc	I	Oct-13-2021
2	Pharmaceutical Innovations, Inc.	II	Jul-12-2019