ICCO - InterCare DX, Inc. (ICCO)

[makinezmoney]

$ICCO : Called it !!!!! We're talking FDA-Approved Medical DEVICE

https://fda.report/PMN/K011625

InterCare Vascular Diagnostic Center - B2623000
The InterCare Vascular Diagnostic Center (Model 300) is a mains electricity (AC-Powered) Vascular laboratory that integrates, into one device, various modules that provide indices of significance to peripheral vascular and cardiovascular function. These modules includes Patient Data, Framingham and BMI, ABIgram(tm) Ankle/Brachial Index, PADogram(tm) Segmental Pressure Analysis, Vasogram(tm) Arterial Compliance procedure and Endogram(tm) Endothelial dysfunction measurement (poor vasodilatory response) through the noninvasive measurement of arterial pulsatile volume changes in the arm of a patient during a reactive hyperemia test (occlusion of blood flow followed by abrupt release). InterCare Vascular Diagnostic Center Model 300 also offers administrative capabilities such as creating periodic system usage reports which show test dates, procedures performed, patient names and physician name. Physically, the system consists of hardware and electronics housed in a cart with four wheels. The device includes a computer board, pneumatic circuit, monitor, keyboard, joystick, printer, tubing, blood pressure cuffs, and power cord. It also incorporates Colin Medical Instruments' Oscillometric blood pressure module M1050, a standard high-end, off-the shelf-NIBP system which has passed UL and SP-10 testing.

http://www.intercare.com/index.html


Company Name: INTERCARE DX, INC.
Model: Vasocor Model 300













Vasocor

An estimated 16.7 million - or 29.2 percent of total global deaths - result from the various forms of CVD, many of which are preventable by action on the major primary risk factors: unhealthy diet, physical inactivity, and smoking. Of the 16.7 million deaths from CVDs every year, 7.2 million are due to ischaemic heart disease, 5.5 million to cerebrovascular disease, and an additional 3.9 million due to hypertension and other heart conditions. The major CVDs include: Coronary (or ischaemic) heart disease (heart attack); Cerebrovascular disease (stroke); Hypertension (high blood pressure); Heart failure; and Rheumatic heart disease.

Despite major efforts by health care professionals, cardiovascular disease remains the primary cause of death in the United States. Half of the victims of sudden cardiac death exhibit no prior symptoms and have no knowledge of their impending health risk.

The InterCare Vascular Diagnostic Center (Vasocor Model 300) was developed to measure vascular health in patients before exhibiting symptoms. It does this by estimating atherosclerotic burden and arterial compliance. The results can be used to assist physicians in assessing and managing patients already demonstrating or with the potential for developing underlying vascular disease. A comprehensive system for measuring atherosclerotic burden, this technology uses segmental plethysmography which measures and records the instantaneous variation in arterial volume in a specific limb segment during each cardiac cycle. Numerous studies support the finding that arterial compliance relates directly to cardiovascular disease or potential of stroke.

The last FDA substantially equivalent letter (K011625) "Intended Use" statement reads:
“The VASOCOR Vascular Diagnostic Center (Model 300) is a non-invasive medical device that can be used by physicians and other health care professionals to measure blood pressure values (systolic, diastolic, and pulse pressure) and the heart pulse rates based on segmental measurement. The Vascular Diagnostic Center (Model 300) also calculated Framingham coronary heart disease, stroke, and peripheral disease risk scores, body mass index (BMI), ankle/brachial index (ABI), and pressure differentials between certain adjacent peripheral limb segments, and provides indication of arterial compliance. The indications of arterial compliance (that is, elasticity indices) can be used to assist in assessing and managing patients that may have potential underlying vascular disease, including cardiovascular disease that might require more specific diagnostic evaluations by physicians or other health care providers.”

This last FDA 510(k) approval for the InterCare Vascular Diagnostics Center (Vasocor Model 300) now meets both the primary (detection of Coronary artery disease) and secondary (evaluation of peripheral vascular disease) objectives for the device.

Furthermore, this new approval also included the ENDogram and the Vasogram technologies which is proprietary, in addition to the ABIgram and PADogram, which are already a common clinical procedure.