Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device electrode, cutaneous
Regulation Description Cutaneous electrode.
Product CodeGXY
Regulation Number 882.1320
Device Class 2


Premarket Reviews
ManufacturerDecision
BAISHENG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIONIT LABS SRL
  SUBSTANTIALLY EQUIVALENT 1
BIOSERENITY MEDICAL DEVICES GROUP
  SUBSTANTIALLY EQUIVALENT 1
BIOWAVE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BOZHOU RONGJIAN MEDICAL APPLIANCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BRAINU CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CERIBELL, INC.
  SUBSTANTIALLY EQUIVALENT 4
COAPT
  SUBSTANTIALLY EQUIVALENT 2
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CYMEDICA ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DYMEDIX DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
  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 1
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEMORY MD, INC.
  SUBSTANTIALLY EQUIVALENT 1
NATUS MANUFACTURING LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PAMEL D.O.O
  SUBSTANTIALLY EQUIVALENT 1
PROLIRA B.V.
  SUBSTANTIALLY EQUIVALENT 1
QUANTALX NEUROSCIENCE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
RHYTHMLINK INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SHAOXING YINGTUO HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN AMYDI-MED ELECTRICS TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DELIDUO MEDICAL TECHNOLOGY 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
2020 11 11
2021 21 21
2022 34 35
2023 25 25
2024 50 50
2025 52 52

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 52 52
Low Readings 21 21
High Readings 20 20
Patient-Device Incompatibility 17 17
Adverse Event Without Identified Device or Use Problem 17 18
Unable to Obtain Readings 13 13
Incorrect Measurement 12 12
Communication or Transmission Problem 7 7
Image Display Error/Artifact 7 7
Improper or Incorrect Procedure or Method 7 7
Insufficient Information 5 5
Use of Device Problem 5 5
Temperature Problem 5 5
Sparking 3 3
Smoking 3 3
Defective Component 3 3
Sharp Edges 3 3
Failure to Analyze Signal 3 3
High impedance 2 2
Material Separation 2 2
Ambient Temperature Problem 2 2
No Apparent Adverse Event 2 2
Erratic or Intermittent Display 2 2
Device Dislodged or Dislocated 2 2
Loose or Intermittent Connection 2 2
Failure to Read Input Signal 1 1
Fitting Problem 1 1
Component or Accessory Incompatibility 1 1
No Visual Prompts/Feedback 1 1
Peeled/Delaminated 1 1
Defective Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Failure to Power Up 1 1
Use of Incorrect Control/Treatment Settings 1 1
Material Deformation 1 1
Product Quality Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 54 54
Skin Inflammation/ Irritation 27 28
Insufficient Information 17 17
Burn(s) 13 13
Superficial (First Degree) Burn 11 11
Rash 11 11
Blister 11 12
Pressure Sores 10 10
Unspecified Tissue Injury 9 9
Erythema 8 9
Skin Discoloration 6 6
Abrasion 6 6
Skin Erosion 5 5
Pain 4 4
Scar Tissue 4 4
Discomfort 4 4
Itching Sensation 4 4
Inflammation 4 4
Device Overstimulation of Tissue 2 2
Choking 2 2
Skin Irritation 2 2
Hypersensitivity/Allergic reaction 2 2
Swelling/ Edema 2 2
Partial thickness (Second Degree) Burn 2 2
Localized Skin Lesion 1 1
Local Reaction 1 1
Reaction to Medicinal Component of Device 1 1
Cramp(s) /Muscle Spasm(s) 1 1
No Known Impact Or Consequence To Patient 1 1
Burn, Thermal 1 1
Injury 1 1
Hematoma 1 1
Burning Sensation 1 1
Necrosis 1 1
No Information 1 1
No Code Available 1 1
Numbness 1 1
Peeling 1 1
Neuropathy 1 1
Skin Tears 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Consequences Or Impact To Patient 1 1
Lead(s), Burn(s) From 1 1
Full thickness (Third Degree) Burn 1 1
Tissue Breakdown 1 1
Skin Burning Sensation 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
-
-