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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 2
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 6
COAPT
  SUBSTANTIALLY EQUIVALENT 2
CYMEDICA ORTHOPEDICS, 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 3
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
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG QIANGNAO TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 21 21
2022 34 35
2023 29 29
2024 60 60
2025 59 59
2026 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 48 48
Patient-Device Incompatibility 42 42
Adverse Event Without Identified Device or Use Problem 22 23
Low Readings 21 21
High Readings 19 19
Unable to Obtain Readings 16 16
Incorrect Measurement 15 15
Improper or Incorrect Procedure or Method 7 7
Communication or Transmission Problem 7 7
Image Display Error/Artifact 7 7
Insufficient Information 6 6
Temperature Problem 5 5
Use of Device Problem 5 5
Sparking 3 3
Failure to Analyze Signal 3 3
Smoking 3 3
Defective Component 3 3
Material Separation 3 3
Sharp Edges 3 3
Device Dislodged or Dislocated 2 2
Erratic or Intermittent Display 2 2
No Apparent Adverse Event 2 2
Ambient Temperature Problem 2 2
Product Quality Problem 2 2
Material Deformation 2 2
High impedance 2 2
Failure to Read Input Signal 2 2
Use of Incorrect Control/Treatment Settings 1 1
Failure to Power Up 1 1
Positioning Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Defective Device 1 1
No Visual Prompts/Feedback 1 1
Off-Label Use 1 1
Missing Information 1 1
Mechanical Problem 1 1
Nonstandard Device 1 1
Component or Accessory Incompatibility 1 1
Display or Visual Feedback Problem 1 1
Fitting Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 59 59
Skin Inflammation/ Irritation 54 55
Rash 19 19
Insufficient Information 19 19
Blister 15 16
Superficial (First Degree) Burn 12 12
Burn(s) 12 12
Pressure Sores 10 10
Erythema 9 10
Pain 9 9
Unspecified Tissue Injury 9 9
Itching Sensation 8 8
Abrasion 6 6
Skin Discoloration 6 6
Hypersensitivity/Allergic reaction 5 5
Skin Erosion 5 5
Inflammation 4 4
Discomfort 4 4
Scar Tissue 4 4
Choking 3 3
Swelling/ Edema 3 3
Device Overstimulation of Tissue 2 2
Skin Tears 2 2
Partial thickness (Second Degree) Burn 2 2
Skin Burning Sensation 2 2
Neuropathy 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Necrosis 1 1
Hematoma 1 1
Peritoneal Laceration(s) 1 1
Local Reaction 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Localized Skin Lesion 1 1
Reaction to Medicinal Component of Device 1 1
Paresthesia 1 1
Burning Sensation 1 1
Numbness 1 1
Peeling 1 1
Tissue Breakdown 1 1
Full thickness (Third Degree) Burn 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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