TPLC - Total Product Life Cycle

• Device: nystagmograph
• Product Code: GWN
• Regulation Number: 882.1460
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
DIZZYDOCTOR SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
GN OTOMETRICS
	SUBSTANTIALLY EQUIVALENT	2
INTERACOUSTICS A/S
	SUBSTANTIALLY EQUIVALENT	4
ISEN TECH & TRADING COMPANY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
ISENT TECH & TRADING COMPANY,LTD.
	SUBSTANTIALLY EQUIVALENT	1
NEURO KINETICS
	SUBSTANTIALLY EQUIVALENT	1
NEURO KINETICS, INC
	SUBSTANTIALLY EQUIVALENT	1
NEURO KINETICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
NEUROBIT TECHNOLOGIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NEUROLIGN USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
OTOTRONIX, LLC
	SUBSTANTIALLY EQUIVALENT	1
RIGHTEYE, LLC
	SUBSTANTIALLY EQUIVALENT	1
SYNAPSYS SA
	SUBSTANTIALLY EQUIVALENT	1
SYNCTHINK, INC.
	SUBSTANTIALLY EQUIVALENT	1
VESTIBULAR FIRST
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	1	1
2019	5	5
2021	1	1
2022	1	1
2023	3	3
2024	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	4	4
Break	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Pressure Problem	1	1
Leak/Splash	1	1
Communication or Transmission Problem	1	1
Output Problem	1	1
Defective Device	1	1
Patient Data Problem	1	1
Failure to Power Up	1	1
Use of Device Problem	1	1
False Positive Result	1	1
Detachment of Device or Device Component	1	1
Fracture	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6	6
Not Applicable	4	4
Pain	2	2
Hearing Impairment	1	1
Skin Inflammation/ Irritation	1	1
Head Injury	1	1
No Known Impact Or Consequence To Patient	1	1
Discomfort	1	1
Visual Impairment	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Integra LifeSciences Corp.	II	Jul-17-2014
2	Neuro Kinetics, Inc.	II	Sep-03-2015
3	Neuro Kinetics, Inc.	II	Jun-12-2015
4	Neuro Kinetics, Inc.	II	Feb-10-2014