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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, cutaneous
Regulation Description Cutaneous electrode.
Product CodeGXY
Regulation Number 882.1320
Device Class 2


Premarket Reviews
ManufacturerDecision
BIONIT LABS SRL
  SUBSTANTIALLY EQUIVALENT 1
BIOSERENITY MEDICAL DEVICES GROUP
  SUBSTANTIALLY EQUIVALENT 1
BIOWAVE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BOZHOU RONGJIAN MEDICAL APPLIANCE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
BRAINU CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
CERIBELL, INC.
  SUBSTANTIALLY EQUIVALENT 3
COAPT
  SUBSTANTIALLY EQUIVALENT 2
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CYMEDICA ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DYMEDIX DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
ELECTRODE MARKET CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
GREEN ISLAND INTERNATIONAL TCM GROUP LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG COMYTENS MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU XINBO ELECTRONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
GYMMAX TECHNOLOGY SHENZHEN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HI-DOW INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEMORY MD INC
  SUBSTANTIALLY EQUIVALENT 1
NATUS MANUFACTURING LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PAMEL D.O.O
  SUBSTANTIALLY EQUIVALENT 1
PROLIRA B.V.
  SUBSTANTIALLY EQUIVALENT 1
QUANTALX NEUROSCIENCE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
RHYTHMLINK INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SHAOXING YINGTUO HEALTHCARE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN AMYDI-MED ELECTRICS TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DELIDUO MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ROUNDWHALE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN XINGYUANLI TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOUTH DAKOTA PARTNERS
  SUBSTANTIALLY EQUIVALENT 1
TONE-A-MATIC INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
VONCARE MEDICAL DEVICE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WELL-LIFE HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
WUHAN GREENTEK PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG QIANGNAO TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 11 11
2021 21 21
2022 34 34
2023 24 24
2024 52 52
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 49 49
High Readings 15 15
Low Readings 15 15
Adverse Event Without Identified Device or Use Problem 14 14
Unable to Obtain Readings 7 7
Incorrect Measurement 6 6
Temperature Problem 5 5
Insufficient Information 4 4
Use of Device Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Sparking 3 3
Image Display Error/Artifact 3 3
Smoking 3 3
Defective Component 3 3
Sharp Edges 3 3
Failure to Analyze Signal 3 3
High impedance 2 2
Patient-Device Incompatibility 2 2
Material Separation 2 2
Ambient Temperature Problem 2 2
Erratic or Intermittent Display 2 2
Device Dislodged or Dislocated 2 2
Loose or Intermittent Connection 2 2
Failure to Read Input Signal 1 1
Fitting Problem 1 1
Component or Accessory Incompatibility 1 1
Communication or Transmission Problem 1 1
No Visual Prompts/Feedback 1 1
Peeled/Delaminated 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Failure to Power Up 1 1
Use of Incorrect Control/Treatment Settings 1 1
Material Deformation 1 1
Product Quality Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
No Apparent Adverse Event 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 43 43
Skin Inflammation/ Irritation 15 15
Insufficient Information 13 13
Burn(s) 10 10
Superficial (First Degree) Burn 9 9
Blister 9 9
Pressure Sores 8 8
Unspecified Tissue Injury 7 7
Erythema 6 6
Abrasion 6 6
Skin Discoloration 6 6
Skin Erosion 5 5
Rash 5 5
Scar Tissue 4 4
Discomfort 4 4
Inflammation 3 3
Device Overstimulation of Tissue 2 2
Itching Sensation 2 2
Skin Irritation 2 2
Choking 2 2
Partial thickness (Second Degree) Burn 2 2
Burn, Thermal 1 1
Localized Skin Lesion 1 1
Reaction to Medicinal Component of Device 1 1
Local Reaction 1 1
No Known Impact Or Consequence To Patient 1 1
Hematoma 1 1
Injury 1 1
No Information 1 1
Necrosis 1 1
Numbness 1 1
No Code Available 1 1
Pain 1 1
Hypersensitivity/Allergic reaction 1 1
Swelling/ Edema 1 1
Skin Tears 1 1
No Consequences Or Impact To Patient 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Lead(s), Burn(s) From 1 1
Tissue Breakdown 1 1
Full thickness (Third Degree) Burn 1 1
Skin Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Coapt LLC II Oct-31-2023
2 Coapt LLC II Oct-31-2023
3 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
4 Neuralynx Inc II May-13-2022
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