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510(k) Data Aggregation
K Number
K172431Device Name
Cardiovascular Analzyer
Manufacturer
PhysioWave, Inc.
Date Cleared
2018-03-14
(215 days)
Product Code
DSB, DSK, DXN
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
PhysioWave, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cardiovascular Analyzer is intended to obtain Pulse Wave Velocity (PWV) and Pulse Rate (PR) through a combination of impedance plethysmography and weight measurements in adults 18 years of age and older. The Cardiovascular Analyzer also measures Body Weight and calculates BMI.
Device Description
The Cardiovascular Analyzer is designed to perform non-invasive physiologic measurements for PWV, PR, and BW, and to calculate BMI. The Cardiovascular Analyzer uses strain gauge sensors to measure BW and the ballistocardiogram (BCG). The BCG provides an indication of the arterial pulsation in the aortic arch. The Cardiovascular Analyzer also uses impedance plethysmography (IPG) sensing to estimate the PR and arterial pulsation in the legs. PWV is then calculated using the subject's sternal height (measured with a height rod) and the Pulse Transit Time (PTT) derived from the BCG and IPG signals.
The Cardiovascular Analyzer is comprised of the following key components and accessories: Scale Platform, Console, USB Cable, Isolated Power Supply and Power Cord, Height Rod, Visual Guide Accessory and Console Wall Mount.
The device uses two sensing modalities (load cells and impedance electrodes) to perform the following three measurements: PWV, PR and BW. BMI is calculated using BW and the operator-entered subject's overall height measurement.
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