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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
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 26 26
2024 52 52
2025 58 58
2026 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 48 48
Patient-Device Incompatibility 24 24
Adverse Event Without Identified Device or Use Problem 21 22
Low Readings 21 21
High Readings 19 19
Unable to Obtain Readings 15 15
Incorrect Measurement 13 13
Communication or Transmission Problem 7 7
Image Display Error/Artifact 7 7
Improper or Incorrect Procedure or Method 7 7
Use of Device Problem 5 5
Temperature Problem 5 5
Insufficient Information 4 4
Sparking 3 3
Smoking 3 3
Defective Component 3 3
Sharp Edges 3 3
Material Separation 3 3
Failure to Analyze Signal 3 3
High impedance 2 2
Material Deformation 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
Failure to Read Input Signal 1 1
Fitting Problem 1 1
Component or Accessory Incompatibility 1 1
No Visual Prompts/Feedback 1 1
Defective Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Failure to Power Up 1 1
Use of Incorrect Control/Treatment Settings 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 56 56
Skin Inflammation/ Irritation 36 37
Insufficient Information 19 19
Rash 14 14
Blister 13 14
Burn(s) 12 12
Superficial (First Degree) Burn 11 11
Pressure Sores 10 10
Unspecified Tissue Injury 9 9
Erythema 7 8
Abrasion 6 6
Skin Discoloration 6 6
Pain 6 6
Itching Sensation 5 5
Skin Erosion 5 5
Inflammation 4 4
Discomfort 4 4
Scar Tissue 4 4
Choking 3 3
Swelling/ Edema 3 3
Hypersensitivity/Allergic reaction 2 2
Device Overstimulation of Tissue 2 2
Partial thickness (Second Degree) Burn 2 2
Skin Tears 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Neuropathy 1 1
Necrosis 1 1
Hematoma 1 1
Local Reaction 1 1
Localized Skin Lesion 1 1
Reaction to Medicinal Component of Device 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Paresthesia 1 1
Burning Sensation 1 1
Numbness 1 1
Peeling 1 1
Full thickness (Third Degree) Burn 1 1
Tissue Breakdown 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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