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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
COLLEGE PARK INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CYMEDICA ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DAEHAN MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
DONG GUAN OU KANG ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DYMEDIX DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELECTRODE MARKET CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ENCEPHALODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG COMYTENS MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU XINBO ELECTRONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
HI-DOW INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 2
HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 2
MEDIA PLUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEMORY MD INC
  SUBSTANTIALLY EQUIVALENT 2
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 DONGZHI ELECTRICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHAOXING YINGTUO HEALTHCARE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BESTPAD TECHNOLOGY DEVELOPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN KONMED TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ROUNDWHALE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
ZMI ELECTRONICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 10 10
2019 19 19
2020 11 11
2021 21 21
2022 34 34
2023 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 30 30
Adverse Event Without Identified Device or Use Problem 16 16
Low Readings 11 11
High Readings 10 10
Temperature Problem 5 5
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Incorrect Measurement 4 4
Erratic or Intermittent Display 3 3
Defective Component 3 3
Smoking 3 3
Use of Device Problem 3 3
Insufficient Information 3 3
Sparking 3 3
Patient-Device Incompatibility 3 3
Device Operates Differently Than Expected 3 3
Sharp Edges 3 3
Device Dislodged or Dislocated 2 2
Ambient Temperature Problem 2 2
Contamination /Decontamination Problem 2 2
Failure to Advance 2 2
Therapeutic or Diagnostic Output Failure 2 2
Failure to Analyze Signal 2 2
Loose or Intermittent Connection 2 2
Unable to Obtain Readings 2 2
High impedance 1 1
Device Emits Odor 1 1
Peeled/Delaminated 1 1
Failure to Power Up 1 1
Product Quality Problem 1 1
Material Separation 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Improper or Incorrect Procedure or Method 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
Communication or Transmission Problem 1 1
Component or Accessory Incompatibility 1 1
Device Markings/Labelling Problem 1 1
Electrical Power Problem 1 1
Human-Device Interface Problem 1 1
Impedance Problem 1 1
No Visual Prompts/Feedback 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 18
No Consequences Or Impact To Patient 15 15
Skin Inflammation/ Irritation 9 9
Burn(s) 8 8
Pressure Sores 6 6
Abrasion 6 6
Skin Irritation 6 6
Scar Tissue 4 4
Skin Discoloration 4 4
Skin Erosion 4 4
Superficial (First Degree) Burn 4 4
Erythema 4 4
Insufficient Information 4 4
Unspecified Tissue Injury 3 3
Discomfort 3 3
No Known Impact Or Consequence To Patient 3 3
Blister 3 3
Lead(s), Burn(s) From 2 2
Partial thickness (Second Degree) Burn 2 2
Rash 2 2
Burn, Thermal 2 2
No Patient Involvement 2 2
Injury 2 2
Inflammation 2 2
Itching Sensation 2 2
Device Overstimulation of Tissue 2 2
Pain 1 1
Pulmonary Edema 1 1
Necrosis 1 1
Hematoma 1 1
Hypersensitivity/Allergic reaction 1 1
Extubate 1 1
Numbness 1 1
Skin Inflammation 1 1
Choking 1 1
Tissue Breakdown 1 1
Local Reaction 1 1
Full thickness (Third Degree) Burn 1 1
No Information 1 1
No Code Available 1 1
Skin Burning Sensation 1 1
Localized Skin Lesion 1 1
Reaction to Medicinal Component of Device 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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