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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 1
COAPT
  SUBSTANTIALLY EQUIVALENT 2
COAPT, LLC
  SUBSTANTIALLY EQUIVALENT 2
COLLEGE PARK INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  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 3
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
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
SOUTH DAKOTA PARTNERS
  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

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 23 23
Adverse Event Without Identified Device or Use Problem 15 15
Low Readings 9 9
High Readings 8 8
Incorrect Measurement 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Smoking 3 3
Use of Device Problem 3 3
Temperature Problem 3 3
Insufficient Information 3 3
Sharp Edges 3 3
Sparking 3 3
Patient-Device Incompatibility 3 3
Device Operates Differently Than Expected 3 3
Failure to Advance 2 2
Loose or Intermittent Connection 2 2
Unable to Obtain Readings 2 2
Failure to Analyze Signal 2 2
Contamination /Decontamination Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Dislodged or Dislocated 2 2
Appropriate Term/Code Not Available 1 1
Device Markings/Labelling Problem 1 1
Electrical Power Problem 1 1
Impedance Problem 1 1
Erratic or Intermittent Display 1 1
No Visual Prompts/Feedback 1 1
Peeled/Delaminated 1 1
Product Quality Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Improper or Incorrect Procedure or Method 1 1
Human-Device Interface Problem 1 1
Device Emits Odor 1 1
Material Separation 1 1
Communication or Transmission Problem 1 1
Component or Accessory Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 15 15
No Clinical Signs, Symptoms or Conditions 11 11
Burn(s) 8 8
Abrasion 6 6
Skin Irritation 6 6
Pressure Sores 5 5
Scar Tissue 4 4
Skin Erosion 4 4
Skin Inflammation/ Irritation 4 4
Discomfort 3 3
Blister 3 3
No Known Impact Or Consequence To Patient 3 3
Erythema 3 3
Insufficient Information 3 3
Superficial (First Degree) Burn 2 2
Skin Discoloration 2 2
Partial thickness (Second Degree) Burn 2 2
Itching Sensation 2 2
Injury 2 2
Burn, Thermal 2 2
No Patient Involvement 2 2
Unspecified Tissue Injury 2 2
Device Overstimulation of Tissue 2 2
Lead(s), Burn(s) From 2 2
Extubate 1 1
Skin Inflammation 1 1
Hematoma 1 1
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1
Pulmonary Edema 1 1
Local Reaction 1 1
No Information 1 1
No Code Available 1 1
Localized Skin Lesion 1 1
Tissue Breakdown 1 1
Full thickness (Third Degree) Burn 1 1
Choking 1 1
Numbness 1 1
Rash 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
2 Neuralynx Inc II May-13-2022
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