Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device device, galvanic skin response measurement
Product CodeGZO
Regulation Number 882.1540
Device Class 2

MDR Year MDR Reports MDR Events
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
Failure to Charge 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity 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
Pulmonary Edema 1 1
Shock 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hudson Scientific LLC II Aug-08-2018
-
-