TPLC - Total Product Life Cycle

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Device	transmitters and receivers, electrocardiograph, telephone
Regulation Description	Telephone electrocardiograph transmitter and receiver.
Product Code	DXH
Regulation Number	870.2920
Device Class	2

Premarket Reviews
Manufacturer	Decision
ALIVECOR, INC.
	SUBSTANTIALLY EQUIVALENT	3
CARRE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
HEARTBEAM, INC.
	SUBSTANTIALLY EQUIVALENT	1
HUINNO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEASURE LABS, INC. (DBA PREEMPTIVEAI, INC.)
	SUBSTANTIALLY EQUIVALENT	1
NANOWEAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
QT MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
SHANDONG CORECARE TECHNOLOGY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
VERILY LIFE SCIENCES, LLC
	SUBSTANTIALLY EQUIVALENT	1
VITALSIGNS TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Power Problem	8	8
Failure to Power Up	4	4
Connection Problem	3	3
Application Program Problem	3	3
Communication or Transmission Problem	2	2
Thermal Decomposition of Device	2	2
No Apparent Adverse Event	2	2
Electrical /Electronic Property Problem	2	2
Excessive Heating	1	1
False Alarm	1	2
Off-Label Use	1	1
Smoking	1	1
False Negative Result	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	29	30
Skin Inflammation/ Irritation	3	3
Insufficient Information	3	3
Chest Pain	2	2
Stroke/CVA	1	1
Hypersensitivity/Allergic reaction	1	1
Burning Sensation	1	1
High Blood Pressure/ Hypertension	1	1
Skin Burning Sensation	1	1
Electric Shock	1	1
Skin Discoloration	1	1
Pain	1	1
Confusion/ Disorientation	1	1
Tingling	1	1
Scar Tissue	1	1
Shock from Patient Lead(s)	1	1
Tachycardia	1	1
Myocardial Infarction	1	1
Itching Sensation	1	1
Bruise/Contusion	1	1
Numbness	1	1
Headache	1	1
Erythema	1	1
Atrial Fibrillation	1	1
Cognitive Changes	1	1
Decreased Appetite	1	1
Dizziness	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	GE Medical Systems China Co., Ltd.	II	Jun-03-2026