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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transmitters and receivers, electrocardiograph, telephone
Product CodeDXH
Regulation Number 870.2920
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED FLUIDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ALIVECOR, INC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K140933  ALIVECOR HEART MONITOR
  2.  K142672  AliveCor Heart Monitor
  3.  K142743  AliveCor Heart Monitor
  4.  K182396  KardiaMobile, KardiaStation
  5.  K183319  Triangle System
  6.  K191406  KardiaMobile, KardiaStation
  7.  K210753  KardiaMobile 6L
  8.  K211668  KardiaMobile Card
  9.  K220350  KardiaMobile 6L
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 9
  1.  K140933  ALIVECOR HEART MONITOR
  2.  K142672  AliveCor Heart Monitor
  3.  K142743  AliveCor Heart Monitor
  4.  K182396  KardiaMobile, KardiaStation
  5.  K183319  Triangle System
  6.  K191406  KardiaMobile, KardiaStation
  7.  K210753  KardiaMobile 6L
  8.  K211668  KardiaMobile Card
  9.  K220350  KardiaMobile 6L
BIOSERENITY SAS
  SUBSTANTIALLY EQUIVALENT 1
BIOTRICITY INC.
  SUBSTANTIALLY EQUIVALENT 1
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARDIAC DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIAC DESIGNS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARDIOCOMM SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOMEDIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
COALA LIFE AB
  SUBSTANTIALLY EQUIVALENT 1
COMMWELL R&D LTD.
  SUBSTANTIALLY EQUIVALENT 1
ECORDUM, INC.
  SUBSTANTIALLY EQUIVALENT 1
EPI MOBILE HEALTH SOLUTIONS (S) PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
G-MEDICAL INNOVATIONS LTD.
  SUBSTANTIALLY EQUIVALENT 2
HEALTHWATCH LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIVMOR
  SUBSTANTIALLY EQUIVALENT 1
MAKROMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEGA ELECTRONICS LTD.
  SUBSTANTIALLY EQUIVALENT 2
NANOWEAR INC.
  SUBSTANTIALLY EQUIVALENT 3
PROTEUS BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
QOMPIUM NV
  SUBSTANTIALLY EQUIVALENT 1
QT MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
QT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
RHYTHMEDIX, LLC
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG CORECARE TECHNOLOGY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SHL TELEMEDICINE INTERNATIONAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
TELOVITAL GMBH TELEMEDIZIN
  SUBSTANTIALLY EQUIVALENT 1
VERILY LIFE SCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 3
VITASYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 2
VIVAQUANT INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2016 4 4
2017 4 4
2020 5 5
2021 2 2
2022 6 6
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Communication or Transmission Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
No Apparent Adverse Event 2 2
Excessive Heating 1 1
Therapeutic or Diagnostic Output Failure 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Incorrect Device Or Component Shipped 1 1
Incorrect Interpretation of Signal 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Smoking 1 1
Vibration 1 1
Device Displays Incorrect Message 1 1
Failure to Fire 1 1
Patient-Device Incompatibility 1 1
Application Program Problem 1 1
Calibration Problem 1 1
Device Alarm System 1 1
False Alarm 1 1
Thermal Decomposition of Device 1 1
Display or Visual Feedback Problem 1 1
False Negative Result 1 1
False Reading From Device Non-Compliance 1 1
Product Quality Problem 1 1
Radio Signal Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
Insufficient Information 3 3
Itching Sensation 2 2
Myocardial Infarction 2 2
Anxiety 2 2
Cardiac Arrest 2 2
Chest Pain 2 2
Erythema 2 2
Pain 2 2
Skin Irritation 1 1
Tachycardia 1 1
Weakness 1 1
Burning Sensation 1 1
Tingling 1 1
Dysphasia 1 1
No Consequences Or Impact To Patient 1 1
Fall 1 1
Head Injury 1 1
Hypersensitivity/Allergic reaction 1 1
Hypoglycemia 1 1
Hypoxia 1 1
Loss of consciousness 1 1
Neck Pain 1 1
Palpitations 1 1
Sleep Dysfunction 1 1
Burn, Thermal 1 1
Ambulation Difficulties 1 1
Abdominal Distention 1 1
Weight Changes 1 1
No Known Impact Or Consequence To Patient 1 1
Shock from Patient Lead(s) 1 1
No Information 1 1
No Code Available 1 1
Skin Inflammation/ Irritation 1 1
Nausea 1 1
Muscle Spasm(s) 1 1
Atrial Fibrillation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alivecor SFO III Feb-18-2015
2 Cybernet Systems Corp. II Feb-25-2010
3 Lifewatch Services Inc II Nov-17-2011
4 Spacelabs Healthcare Inc II Oct-30-2015
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