# K211585: Bodyport Cardiac Scale

- Pathway: 510(k) (Traditional)
- Applicant: Bodyport, Inc.
- Decided: Jul 29, 2022 after 431 days
- Product code: DSB (Plethysmograph, Impedance)
- Device class: 2
- Regulation: 21 CFR 870.2770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K922218 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133301: Zoe Fluid Status Monitor, Noninvasive Medical Technologies, Inc. (2014) Summary page 4.

## Indications for 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 duration of 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.

Source page: https://510kreport.com/device/K211585
Methodology: https://510kreport.com/methodology