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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device media, electroconductive
Product CodeGYB
Regulation Number 882.1275
Device Class 2


Premarket Reviews
ManufacturerDecision
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
2019 3 3
2020 2 2
2021 4 4
2022 4 4
2023 6 6
2024 4 4

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Irritation 3 3
Partial thickness (Second Degree) Burn 3 3
Hypersensitivity/Allergic reaction 2 2
Corneal Abrasion 2 2
Skin Inflammation/ Irritation 2 2
Insufficient Information 2 2
Eye Pain 2 2
Full thickness (Third Degree) Burn 2 2
Superficial (First Degree) Burn 1 1
Nausea 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Malaise 1 1
Itching Sensation 1 1
Local Reaction 1 1
Cardiac Arrest 1 1
Burn(s) 1 1
Rash 1 1
Skin Erosion 1 1
Burning Sensation 1 1
Swelling 1 1
Discomfort 1 1
Hair Loss 1 1
Contact Dermatitis 1 1
Unspecified Tissue Injury 1 1
Convulsion/Seizure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 National Distribution & Contracting Inc I Oct-13-2021
2 Natus Neurology Inc II Mar-19-2024
3 Parker Laboratories, Inc. II Apr-19-2024
4 Parker Laboratories, Inc. II Feb-29-2024
5 Pharmaceutical Innovations, Inc. II Jul-12-2019
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