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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
AMPCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
ASPECT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
AXELGAARD MFG. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
AXIOBIONICS LLC
  SUBSTANTIALLY EQUIVALENT 1
BIO PROTECH, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIO-MEDICAL RESEARCH, LTD.
  SUBSTANTIALLY EQUIVALENT 3
BIOWAVE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BOZHOU RONGJIAN MEDICAL APPLIANCE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
CATHAY MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 1
CERIBELL, INC.
  SUBSTANTIALLY EQUIVALENT 4
COAPT
  SUBSTANTIALLY EQUIVALENT 2
COAPT, LLC
  SUBSTANTIALLY EQUIVALENT 3
COLLEGE PARK INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 3
COVIDIEN LP
  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
DRTV ASIA LTD
  SUBSTANTIALLY EQUIVALENT 1
DYMEDIX DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DYNATRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DYNATRONICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
ELECTRO-CAP INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
ELECTRODE MARKET CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
EMBLA SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
EMSI
  SUBSTANTIALLY EQUIVALENT 1
ENCEPHALODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ESWALLOW USA
  SUBSTANTIALLY EQUIVALENT 1
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
FIAB SPA
  SUBSTANTIALLY EQUIVALENT 1
GMDASZ MANUFACTURING CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
GRASS TECHNOLOGIES, AN ASTRO-MED, INC. PRODUCT GRO
  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 5
GYMMAX TECHNOLOGY SHENZHEN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HI-DOW INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 2
HIVOX BIOTEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
HYDRODOT, INC
  SUBSTANTIALLY EQUIVALENT 1
INCEREB LTD
  SUBSTANTIALLY EQUIVALENT 1
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 3
IVES EGG SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU ZEKANG MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
LEONHARD LANG GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDIA PLUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDICO ELECTRODES INTERNATIONAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEMORY MD INC
  SUBSTANTIALLY EQUIVALENT 2
MOTION MEDICAL PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
NATUS MANUFACTURING LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NEURO RESOURCE GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEUROMETRIX, INC.
  SUBSTANTIALLY EQUIVALENT 3
NEUROVIRTUAL USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMRON HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
OTTO BOCK AUSTRIA
  SUBSTANTIALLY EQUIVALENT 1
OTTO BOCK HEALTHCARE PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 1
PAMEL D.O.O
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS CONSUMER LIFESTYLE
  SUBSTANTIALLY EQUIVALENT 1
PHOENIX MEDICAL DEVICES, LLP
  SUBSTANTIALLY EQUIVALENT 1
PMT CORP.
  SUBSTANTIALLY EQUIVALENT 1
PROLIRA B.V.
  SUBSTANTIALLY EQUIVALENT 1
RENO MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
RENO MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
RHYTHMLINK INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 4
ROCHESTER ELECTRO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SANIBEL SUPPLY
  SUBSTANTIALLY EQUIVALENT 1
SELECTIVE MED COMPONENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 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 DONGDIXIN TECHNOLOGY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN KONMED TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MAILUOKANG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN QUALITY MEDICAL TECHNOLOGY 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
SPES MEDICA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU ENNOVA ELECTRONICS TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
THE ELECTRODE STORE, INC.
  SUBSTANTIALLY EQUIVALENT 1
TONE-A-MATIC INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
TOP-RANK HEALTH CARE EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRANSFER TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
VONCARE MEDICAL DEVICE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WANDY RUBBER INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WAVI, CO
  SUBSTANTIALLY EQUIVALENT 1
WELL-LIFE HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 2
WUHAN GREENTEK PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
XIAN FRIENDSHIP MEDICAL ELECTRONICS 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
2014 11 11
2015 19 19
2016 15 15
2017 11 11
2018 10 10
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 34 34
Low Readings 17 17
High Readings 16 16
Insufficient Information 14 14
Device Operates Differently Than Expected 8 8
Device-Device Incompatibility 8 8
Use of Device Problem 7 7
Incorrect Measurement 7 7
Patient-Device Incompatibility 6 6
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Temperature Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Unable to Obtain Readings 4 4
Erratic or Intermittent Display 3 3
Sharp Edges 3 3
Defective Component 3 3
Smoking 3 3
Material Separation 3 3
Sparking 3 3
Compatibility Problem 3 3
Contamination /Decontamination Problem 2 2
Ambient Temperature Problem 2 2
Failure to Analyze Signal 2 2
Loose or Intermittent Connection 2 2
Therapeutic or Diagnostic Output Failure 2 2
Failure to Discharge 2 2
Device Dislodged or Dislocated 2 2
Failure to Advance 2 2
Device Contamination with Chemical or Other Material 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Failure to Power Up 1 1
Product Quality Problem 1 1
No Apparent Adverse Event 1 1
Device Emits Odor 1 1
Overheating of Device 1 1
Separation Failure 1 1
Display or Visual Feedback Problem 1 1
Image Display Error/Artifact 1 1
Peeled/Delaminated 1 1
Positioning Problem 1 1
Device Markings/Labelling Problem 1 1
Impedance Problem 1 1
Human-Device Interface Problem 1 1
Electrical Power Problem 1 1
Component Falling 1 1
No Visual Prompts/Feedback 1 1
Migration or Expulsion of Device 1 1
Communication or Transmission Problem 1 1
High impedance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 38 38
Burn(s) 19 19
No Consequences Or Impact To Patient 15 15
Skin Inflammation/ Irritation 14 14
Injury 13 13
Partial thickness (Second Degree) Burn 12 12
Skin Irritation 11 11
Burn, Thermal 10 10
Blister 9 9
Pressure Sores 8 8
Superficial (First Degree) Burn 7 7
Insufficient Information 7 7
Abrasion 7 7
No Known Impact Or Consequence To Patient 7 7
Rash 7 7
Skin Discoloration 6 6
Erythema 6 6
Unspecified Tissue Injury 6 6
Scar Tissue 5 5
Pain 5 5
Full thickness (Third Degree) Burn 4 4
No Information 4 4
Skin Erosion 4 4
Reaction 3 3
Lead(s), Burn(s) From 3 3
Inflammation 3 3
Itching Sensation 3 3
Tissue Damage 3 3
Discomfort 3 3
Swelling 3 3
Skin Inflammation 3 3
Choking 2 2
No Patient Involvement 2 2
Burning Sensation 2 2
Device Overstimulation of Tissue 2 2
Hypersensitivity/Allergic reaction 2 2
Swelling/ Edema 1 1
Pulmonary Edema 1 1
Discharge 1 1
Pupillary Block 1 1
Hemorrhage/Bleeding 1 1
Eye Injury 1 1
Extubate 1 1
Tissue Breakdown 1 1
Fluid Discharge 1 1
Skin Burning Sensation 1 1
Fall 1 1
Laceration(s) 1 1
Numbness 1 1
Chest Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Axiobionics, LLC II Aug-01-2011
2 Coapt LLC II Oct-31-2023
3 Coapt LLC II Oct-31-2023
4 Covidien LLC dba Uni-Patch II Dec-10-2012
5 International Rehabilitative Sciences, Inc. II Jun-26-2015
6 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
7 Medtronic Navigation, Inc. II May-09-2014
8 NAImco Inc dba Richmar Inc II Feb-14-2013
9 Nellcor Puritan Bennett Inc. (dba Covidien LP) I Jan-26-2012
10 Neuralynx Inc II May-13-2022
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