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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
GYMMAX TECHNOLOGY SHENZHEN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HI-DOW INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 2
HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED
  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
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 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 40 40
Adverse Event Without Identified Device or Use Problem 16 16
High Readings 15 15
Low Readings 14 14
Incorrect Measurement 6 6
Temperature Problem 5 5
Improper or Incorrect Procedure or Method 4 4
Unable to Obtain Readings 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Use of Device Problem 4 4
Patient-Device Incompatibility 3 3
Sharp Edges 3 3
Defective Component 3 3
Smoking 3 3
Sparking 3 3
Erratic or Intermittent Display 3 3
Insufficient Information 3 3
Ambient Temperature Problem 2 2
Loose or Intermittent Connection 2 2
Material Separation 2 2
Device Dislodged or Dislocated 2 2
Contamination /Decontamination Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Failure to Analyze Signal 2 2
Product Quality Problem 1 1
No Apparent Adverse Event 1 1
Device Emits Odor 1 1
High impedance 1 1
No Visual Prompts/Feedback 1 1
Display or Visual Feedback Problem 1 1
Failure to Power Up 1 1
Device Markings/Labelling Problem 1 1
Fitting Problem 1 1
Appropriate Term/Code Not Available 1 1
Component or Accessory Incompatibility 1 1
Image Display Error/Artifact 1 1
Use of Incorrect Control/Treatment Settings 1 1
Peeled/Delaminated 1 1
Communication or Transmission Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 38 38
Skin Inflammation/ Irritation 14 14
Blister 9 9
Burn(s) 9 9
No Consequences Or Impact To Patient 9 9
Insufficient Information 7 7
Superficial (First Degree) Burn 7 7
Unspecified Tissue Injury 6 6
Pressure Sores 6 6
Abrasion 6 6
Erythema 5 5
Skin Irritation 5 5
Skin Erosion 4 4
Scar Tissue 4 4
Skin Discoloration 4 4
Rash 4 4
Inflammation 3 3
Discomfort 2 2
Lead(s), Burn(s) From 2 2
No Known Impact Or Consequence To Patient 2 2
Device Overstimulation of Tissue 2 2
Burn, Thermal 2 2
Partial thickness (Second Degree) Burn 2 2
Itching Sensation 2 2
Choking 2 2
No Patient Involvement 2 2
Swelling/ Edema 1 1
Numbness 1 1
Reaction to Medicinal Component of Device 1 1
Injury 1 1
Local Reaction 1 1
Pain 1 1
Extubate 1 1
Tissue Breakdown 1 1
No Information 1 1
Full thickness (Third Degree) Burn 1 1
Hematoma 1 1
Necrosis 1 1
Skin Burning Sensation 1 1
Localized Skin Lesion 1 1
Hypersensitivity/Allergic reaction 1 1
No Code Available 1 1
Skin Inflammation 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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