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
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
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CYMEDICA ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DAEHAN MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DYMEDIX DIAGNOSTICS, INC.
  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 2
HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEMORY MD INC
  SUBSTANTIALLY EQUIVALENT 1
NATUS MANUFACTURING LIMITED
  SUBSTANTIALLY EQUIVALENT 1
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 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 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
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 16 16
High Readings 15 15
Low Readings 14 14
Incorrect Measurement 6 6
Temperature Problem 5 5
Improper or Incorrect Procedure or Method 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Unable to Obtain Readings 4 4
Use of Device Problem 4 4
Erratic or Intermittent Display 3 3
Sparking 3 3
Insufficient Information 3 3
Patient-Device Incompatibility 3 3
Smoking 3 3
Defective Component 3 3
Sharp Edges 3 3
Device Dislodged or Dislocated 2 2
Failure to Analyze Signal 2 2
Loose or Intermittent Connection 2 2
Therapeutic or Diagnostic Output Failure 2 2
Contamination /Decontamination Problem 2 2
Material Separation 2 2
Ambient Temperature Problem 2 2
Appropriate Term/Code Not Available 1 1
Display or Visual Feedback Problem 1 1
Component or Accessory Incompatibility 1 1
Fitting Problem 1 1
No Visual Prompts/Feedback 1 1
Communication or Transmission Problem 1 1
High impedance 1 1
Peeled/Delaminated 1 1
Device Markings/Labelling Problem 1 1
Image Display Error/Artifact 1 1
Failure to Power Up 1 1
Use of Incorrect Control/Treatment Settings 1 1
Device Emits Odor 1 1
Product Quality Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 38 38
Skin Inflammation/ Irritation 14 14
No Consequences Or Impact To Patient 9 9
Blister 9 9
Burn(s) 9 9
Superficial (First Degree) Burn 7 7
Insufficient Information 7 7
Pressure Sores 6 6
Unspecified Tissue Injury 6 6
Abrasion 6 6
Skin Irritation 5 5
Erythema 5 5
Scar Tissue 4 4
Skin Discoloration 4 4
Skin Erosion 4 4
Rash 4 4
Inflammation 3 3
Lead(s), Burn(s) From 2 2
Partial thickness (Second Degree) Burn 2 2
Choking 2 2
No Patient Involvement 2 2
Discomfort 2 2
No Known Impact Or Consequence To Patient 2 2
Device Overstimulation of Tissue 2 2
Burn, Thermal 2 2
Itching Sensation 2 2
Injury 1 1
Reaction to Medicinal Component of Device 1 1
Numbness 1 1
Skin Inflammation 1 1
Localized Skin Lesion 1 1
Pain 1 1
Local Reaction 1 1
Hematoma 1 1
Swelling/ Edema 1 1
No Information 1 1
Necrosis 1 1
No Code Available 1 1
Extubate 1 1
Hypersensitivity/Allergic reaction 1 1
Tissue Breakdown 1 1
Full thickness (Third Degree) Burn 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
-
-