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TPLC
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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
1. K141872
SUDOSCAN
IMPETO MEDICAL INC
SUBSTANTIALLY EQUIVALENT
1
1. K141872
SUDOSCAN
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
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