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 2
BIOSERENITY MEDICAL DEVICES GROUP
  SUBSTANTIALLY EQUIVALENT 1
BIOWAVE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BOZHOU RONGJIAN MEDICAL APPLIANCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BRAINU CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CADWELL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CERIBELL, INC.
  SUBSTANTIALLY EQUIVALENT 6
COAPT
  SUBSTANTIALLY EQUIVALENT 2
CYMEDICA ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN TUTAMEN METALWORK CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
ELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETI
  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 3
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
OTTO BOCK HEALTHCARE PRODUCTS GMBH
  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
TECHNOMED EUROPE
  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
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG QIANGNAO TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 21 21
2022 34 35
2023 29 29
2024 60 60
2025 59 59
2026 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 48 48
Patient-Device Incompatibility 46 46
High Readings 23 23
Low Readings 21 21
Incorrect Measurement 19 19
Unable to Obtain Readings 18 18
Adverse Event Without Identified Device or Use Problem 14 14
Communication or Transmission Problem 11 11
Image Display Error/Artifact 7 7
Improper or Incorrect Procedure or Method 7 7
Insufficient Device Problem Information 6 6
Use of Device Problem 4 4
Temperature Problem 4 4
Defective Component 3 3
Material Separation 3 3
Failure to Analyze Signal 3 3
Sharp Edges 3 3
High impedance 2 2
Material Deformation 2 2
Failure to Read Input Signal 2 2
Display or Visual Feedback Problem 2 2
No Apparent Adverse Event 2 2
Erratic or Intermittent Display 2 2
Ambient Temperature Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Dislodged or Dislocated 2 2
Failure to Power Up 1 1
Sparking 1 1
Device Alarm System 1 1
Smoking 1 1
Fitting Problem 1 1
No Visual Prompts/Feedback 1 1
Component or Accessory Incompatibility 1 1
Missing Information 1 1
Use of Incorrect Control/Treatment Settings 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 64 64
Skin Inflammation/ Irritation 58 59
Insufficient Information 22 22
Rash 21 21
Blister 16 17
Burn(s) 15 15
Pressure Sore/Ulcer 13 13
Superficial (First Degree) Burn 13 13
Pain 11 11
Unspecified Tissue Injury 9 9
Erythema 9 10
Skin Discoloration 8 8
Itching Sensation 8 8
Abrasion 6 6
Hypersensitivity/Allergic reaction 6 6
Discomfort 5 5
Skin Erosion 5 5
Scar Tissue 4 4
Swelling/ Edema 4 4
Inflammation 4 4
Choking 3 3
Partial thickness (Second Degree) Burn 2 2
Skin Burning Sensation 2 2
Skin Tears 2 2
Device Overstimulation of Tissue 2 2
Restless Legs Syndrome 1 1
Paresthesia 1 1
Bruise/Contusion 1 1
Localized Skin Lesion 1 1
Neuropathy 1 1
Full thickness (Third Degree) Burn 1 1
Hematoma 1 1
Reaction to Medicinal Component of Device 1 1
Numbness 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Local Reaction 1 1
Tissue Breakdown 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1
Peeling 1 1
Necrosis 1 1
Burning Sensation 1 1
Peritoneal Laceration(s) 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
-
-