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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
BAISHENG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 4
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 35
2023 25 25
2024 50 50
2025 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 52 52
Low Readings 21 21
High Readings 20 20
Adverse Event Without Identified Device or Use Problem 16 17
Patient-Device Incompatibility 15 15
Unable to Obtain Readings 13 13
Incorrect Measurement 11 11
Communication or Transmission Problem 7 7
Image Display Error/Artifact 7 7
Improper or Incorrect Procedure or Method 6 6
Insufficient Information 5 5
Use of Device Problem 5 5
Temperature Problem 5 5
Sparking 3 3
Smoking 3 3
Defective Component 3 3
Sharp Edges 3 3
Failure to Analyze Signal 3 3
High impedance 2 2
Material Separation 2 2
Ambient Temperature Problem 2 2
No Apparent Adverse Event 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
No Visual Prompts/Feedback 1 1
Peeled/Delaminated 1 1
Defective Device 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
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 53 53
Skin Inflammation/ Irritation 25 26
Insufficient Information 17 17
Superficial (First Degree) Burn 11 11
Blister 11 12
Burn(s) 11 11
Pressure Sores 10 10
Unspecified Tissue Injury 9 9
Rash 9 9
Erythema 8 9
Abrasion 6 6
Skin Discoloration 6 6
Skin Erosion 5 5
Inflammation 4 4
Itching Sensation 4 4
Scar Tissue 4 4
Pain 4 4
Discomfort 4 4
Skin Irritation 2 2
Partial thickness (Second Degree) Burn 2 2
Swelling/ Edema 2 2
Choking 2 2
Device Overstimulation of Tissue 2 2
Skin Burning Sensation 1 1
Full thickness (Third Degree) Burn 1 1
Tissue Breakdown 1 1
Lead(s), Burn(s) From 1 1
No Consequences Or Impact To Patient 1 1
Skin Tears 1 1
Peeling 1 1
Numbness 1 1
Injury 1 1
Burning Sensation 1 1
No Known Impact Or Consequence To Patient 1 1
Reaction to Medicinal Component of Device 1 1
Localized Skin Lesion 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Burn, Thermal 1 1
Local Reaction 1 1
Hematoma 1 1
No Information 1 1
Necrosis 1 1
No Code Available 1 1
Hypersensitivity/Allergic reaction 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Neuropathy 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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