TPLC - Total Product Life Cycle

• Device: device, galvanic skin response measurement
• Product Code: GZO
• Regulation Number: 882.1540
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
IMPETO MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
IMPETO MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
L.D. TECHNOLOGY, LLC
	SUBSTANTIALLY EQUIVALENT	1
LD TECHNOLOGY LLC
	SUBSTANTIALLY EQUIVALENT	2
MEDEIA, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZYTO TECHNOLOGIES, INC
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	1	1
2017	1	1
2018	19	19
2021	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Inappropriate/Inadequate Shock/Stimulation	7	7
Nonstandard Device	5	5
Installation-Related Problem	2	2
Protective Measures Problem	2	2
Insufficient Information	1	1
Failure to Charge	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Integrity Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Electric Shock	9	9
No Known Impact Or Consequence To Patient	4	4
No Information	2	2
Palpitations	2	2
Hematoma	2	2
Hypersensitivity/Allergic reaction	1	1
Pain	1	1
Pulmonary Edema	1	1
Shock	1	1
Vertigo	1	1
Chills	1	1
Dizziness	1	1
Electrolyte Imbalance	1	1
No Consequences Or Impact To Patient	1	1
Cardiac Arrest	1	1
Death	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Hudson Scientific LLC	II	Aug-08-2018
2	ZYTO Technologies, Inc.	II	Jul-01-2016