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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 2
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
DONGGUAN TUTAMEN METALWORK CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
ELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETI
  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
OTTO BOCK HEALTHCARE PRODUCTS GMBH
  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
TECHNOMED EUROPE
  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 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 49 49
Patient-Device Incompatibility 46 46
Adverse Event Without Identified Device or Use Problem 22 23
Low Readings 21 21
High Readings 20 20
Incorrect Measurement 17 17
Unable to Obtain Readings 16 16
Communication or Transmission Problem 8 8
Improper or Incorrect Procedure or Method 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
Display or Visual Feedback Problem 2 2
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
Device Alarm System 1 1
No Visual Prompts/Feedback 1 1
Missing Information 1 1
Off-Label Use 1 1
Mechanical Problem 1 1
Nonstandard Device 1 1
Component or Accessory Incompatibility 1 1
Fitting Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 62 62
Skin Inflammation/ Irritation 57 58
Rash 20 20
Insufficient Information 19 19
Blister 15 16
Superficial (First Degree) Burn 12 12
Burn(s) 12 12
Pressure Sores 10 10
Pain 10 10
Unspecified Tissue Injury 9 9
Erythema 9 10
Itching Sensation 8 8
Hypersensitivity/Allergic reaction 6 6
Abrasion 6 6
Skin Discoloration 6 6
Discomfort 5 5
Skin Erosion 5 5
Inflammation 4 4
Scar Tissue 4 4
Swelling/ Edema 3 3
Choking 3 3
Skin Burning Sensation 2 2
Partial thickness (Second Degree) Burn 2 2
Skin Tears 2 2
Device Overstimulation of Tissue 2 2
Burning Sensation 1 1
Paresthesia 1 1
Numbness 1 1
Reaction to Medicinal Component of Device 1 1
Peeling 1 1
Localized Skin Lesion 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Local Reaction 1 1
Peritoneal Laceration(s) 1 1
Hematoma 1 1
Necrosis 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Tissue Breakdown 1 1
Full thickness (Third Degree) Burn 1 1
Bruise/Contusion 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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