TPLC - Total Product Life Cycle

show TPLC since

Device	transmitters and receivers, electrocardiograph, telephone
Product Code	DXH
Regulation Number	870.2920
Device Class	2

Premarket Reviews
Manufacturer	Decision
ADVANCED FLUIDICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ALIVECOR, INC
	SUBSTANTIALLY EQUIVALENT	1
ALIVECOR, INC.
	SUBSTANTIALLY EQUIVALENT	9
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

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