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510(k) Data Aggregation
K Number
K211585Device Name
Bodyport Cardiac Scale
Manufacturer
Bodyport Inc.
Date Cleared
2022-07-29
(431 days)
Product Code
DSB
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
Bodyport Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bodyport Cardiac Scale is intended for use, under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management related health conditions. The device is intended to be used to measure and track body weight, peripheral impedance, pulse rate, and center of pressure. The device is intended to be used in the home or clinic environment.
Intended users are people over 21 years of age who can stand for the measurement and weigh less than 180 kg (397 lbs).
The device does not generate any real-time alarms for consideration by the user at home or by a healthcare professional. Data from the device should be used in the context of all clinical data to make determinations of a patient's status.
Device Description
The Bodyport Cardiac Scale is a non-invasive cardiovascular monitor and body weight scale that measures body weight, peripheral impedance, pulse rate, and center of pressure through the feet of a user standing on its surface. The device is powered by four (4) AA alkaline batteries.
The device is comprised of a physical platform on which the user stands with bare feet. Four electrodes located on the top surface of the platform are used to measure of the user's lower body (foot-to-foot). The impedance signal is obtained by applying a small, safe battery-generated current (<500uA) between the feet of the user and measuring the resulting electrical potential. The impedance signal reflects the electrical resistance of the lower body and is modulated by changes in fluid levels and blood flow in the lower part of the body, enabling the calculation of parameters such as pulse rate and peripheral impedance. The impedance signal is captured at two frequencies (8kHz) to enable the calculation of peripheral impedance values that reflect intra- and extra-cellular fluid levels. The 64kHz signal is used to calculate impedance magnitude and phase angle to measure pulse rate.
Additionally, load cells in each of the four corners of the device measure the static and dynamic loads being applied to the device by the user's body. The load cells are used to measure the user's body weight and center of pressure. The device may show body weight, peripheral impedance, and pulse rate information on a display integrated into the platform.
A user is instructed to stand on the Bodyport Cardiac Scale with bare feet. The measurement starts automatically when the user steps on the scale. The device acquires the data and notifies the user that the measurement is complete through a gentle haptic vibration and displays the results on the device screen. Data collected by the Bodyport Cardiac Scale is automatically transmitted via cellular communication to the Bodyport cloud where it can be accessed through a supported web-based browser, dashboard or API.
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