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U.S. Department of Health and Human Services

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


Premarket Reviews
ManufacturerDecision
BIOWAVE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BOZHOU RONGJIAN MEDICAL APPLIANCE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
CERIBELL, INC.
  SUBSTANTIALLY EQUIVALENT 3
COAPT
  SUBSTANTIALLY EQUIVALENT 2
COAPT, LLC
  SUBSTANTIALLY EQUIVALENT 2
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CYMEDICA ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DAEHAN MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DYMEDIX DIAGNOSTICS, INC.
  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
HI-DOW INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 2
HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEMORY MD INC
  SUBSTANTIALLY EQUIVALENT 1
OTTO BOCK HEALTHCARE PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 1
PAMEL D.O.O
  SUBSTANTIALLY EQUIVALENT 1
PROLIRA B.V.
  SUBSTANTIALLY EQUIVALENT 1
RHYTHMLINK INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
SHAOXING DL HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHAOXING YINGTUO HEALTHCARE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN AMYDI-MED ELECTRICS TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BESTPAD TECHNOLOGY DEVELOPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKE CONNECT ELECTRONICS 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
2019 19 19
2020 11 11
2021 21 21
2022 34 34
2023 24 24
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 33 33
Adverse Event Without Identified Device or Use Problem 16 16
High Readings 14 14
Low Readings 14 14
Temperature Problem 5 5
Incorrect Measurement 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Use of Device Problem 4 4
Smoking 3 3
Defective Component 3 3
Erratic or Intermittent Display 3 3
Unable to Obtain Readings 3 3
Sharp Edges 3 3
Sparking 3 3
Patient-Device Incompatibility 3 3
Ambient Temperature Problem 2 2
Contamination /Decontamination Problem 2 2
Insufficient Information 2 2
Therapeutic or Diagnostic Output Failure 2 2
Loose or Intermittent Connection 2 2
Failure to Analyze Signal 2 2
Material Separation 2 2
Device Dislodged or Dislocated 2 2
Inappropriate/Inadequate Shock/Stimulation 1 1
Improper or Incorrect Procedure or Method 1 1
High impedance 1 1
Device Emits Odor 1 1
Peeled/Delaminated 1 1
Failure to Power Up 1 1
Product Quality Problem 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
No Visual Prompts/Feedback 1 1
Communication or Transmission Problem 1 1
Component or Accessory Incompatibility 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30 30
Skin Inflammation/ Irritation 11 11
No Consequences Or Impact To Patient 9 9
Burn(s) 7 7
Pressure Sores 6 6
Abrasion 6 6
Insufficient Information 6 6
Skin Irritation 5 5
Superficial (First Degree) Burn 5 5
Blister 4 4
Scar Tissue 4 4
Skin Discoloration 4 4
Skin Erosion 4 4
Erythema 4 4
Rash 3 3
Unspecified Tissue Injury 3 3
Lead(s), Burn(s) From 2 2
No Known Impact Or Consequence To Patient 2 2
Partial thickness (Second Degree) Burn 2 2
Choking 2 2
Burn, Thermal 2 2
No Patient Involvement 2 2
Discomfort 2 2
Inflammation 2 2
Itching Sensation 2 2
Device Overstimulation of Tissue 2 2
Pain 1 1
Necrosis 1 1
Hematoma 1 1
Hypersensitivity/Allergic reaction 1 1
Injury 1 1
Extubate 1 1
Numbness 1 1
Skin Inflammation 1 1
Local Reaction 1 1
Tissue Breakdown 1 1
Full thickness (Third Degree) Burn 1 1
No Information 1 1
No Code Available 1 1
Reaction to Medicinal Component of Device 1 1
Skin Burning Sensation 1 1
Localized Skin Lesion 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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