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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 2
COAPT, LLC
  SUBSTANTIALLY EQUIVALENT 3
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
EMBLA SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ENCEPHALODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EVERYWAY MEDICAL INSTRUMENTS 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
IVES EGG SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
MEDIA PLUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEMORY MD INC
  SUBSTANTIALLY EQUIVALENT 2
NEUROVIRTUAL USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
OTTO BOCK HEALTHCARE PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 1
PAMEL D.O.O
  SUBSTANTIALLY EQUIVALENT 1
RENO MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
RHYTHMLINK INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 3
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 QUALITY MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
VONCARE MEDICAL DEVICE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WAVI, CO
  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
2017 11 11
2018 10 10
2019 19 19
2020 11 11
2021 21 21
2022 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 20 20
Adverse Event Without Identified Device or Use Problem 19 19
Low Readings 9 9
High Readings 6 6
Device Operates Differently Than Expected 6 6
Patient-Device Incompatibility 4 4
Use of Device Problem 4 4
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
Incorrect Measurement 3 3
Smoking 3 3
Sparking 3 3
Insufficient Information 3 3
Sharp Edges 3 3
Temperature Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Contamination /Decontamination Problem 2 2
Device Dislodged or Dislocated 2 2
Loose or Intermittent Connection 2 2
Failure to Advance 2 2
Improper or Incorrect Procedure or Method 1 1
Component Falling 1 1
Erratic or Intermittent Display 1 1
Device Emits Odor 1 1
Peeled/Delaminated 1 1
Product Quality Problem 1 1
Unable to Obtain Readings 1 1
Failure to Analyze Signal 1 1
Material Separation 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Electrical Power Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Human-Device Interface Problem 1 1
Impedance Problem 1 1
Device Markings/Labelling Problem 1 1
Appropriate Term/Code Not Available 1 1
No Visual Prompts/Feedback 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 15 15
Skin Irritation 7 7
Abrasion 7 7
Burn(s) 7 7
No Clinical Signs, Symptoms or Conditions 6 6
Pressure Sores 5 5
Scar Tissue 4 4
Skin Erosion 4 4
Skin Inflammation/ Irritation 4 4
No Information 4 4
Insufficient Information 3 3
Erythema 3 3
Discomfort 3 3
Injury 3 3
No Known Impact Or Consequence To Patient 3 3
Partial thickness (Second Degree) Burn 3 3
Lead(s), Burn(s) From 3 3
Burning Sensation 2 2
Burn, Thermal 2 2
No Patient Involvement 2 2
Superficial (First Degree) Burn 2 2
Itching Sensation 2 2
Skin Discoloration 2 2
Device Overstimulation of Tissue 2 2
Pain 2 2
Blister 2 2
Localized Skin Lesion 1 1
No Code Available 1 1
Unspecified Tissue Injury 1 1
Pulmonary Edema 1 1
Rash 1 1
Local Reaction 1 1
Abdominal Pain 1 1
Muscle Weakness 1 1
Chest Pain 1 1
Fall 1 1
Bone Fracture(s) 1 1
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1
Swelling 1 1
Full thickness (Third Degree) Burn 1 1
Extubate 1 1
Reaction 1 1
Numbness 1 1
Skin Inflammation 1 1
Choking 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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