# K260224: MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)

- Pathway: 510(k) (Traditional)
- Applicant: ImpediMed Limited
- Decided: Aug 17, 2026 after 203 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: 10 generations back to K922218 (1992). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232089: SOZO Pro, ImpediMed Limited (2023) Summary page 6.

## Indications for use
The MySOZO Software version 6.1.0.1 (SW Version 6.1.0.1) is intended for adult patients living with heart failure. This device is intended for use, under the direction of a physician, for the noninvasive monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data. For adult human patients at risk of lymphedema: A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of lymphedema. The use of the device to obtain an L-Dex score is only indicated for patients who will have or who have had lymph nodes, from the axillary and/or pelvic regions, either removed, damaged or irradiated. The MySOZO Software version 6.1.0.1 (SW Version 6.1.0.1) may be used as an adjunct to existing methods by aiding clinicians who are using Subjective Global Assessment (SGA) tools to assess patients at risk of protein-calorie malnutrition (PCM), and to aid in assessing patients at risk of sarcopenia, a disease of low muscle mass or muscle loss. The MySOZO Software version 6.1.0.1 (SW Version 6.1.0.1) may be further used to estimate the following body composition parameters in humans to track clinically relevant body composition parameters over time: • Fat mass • Fat mass index (FMI) • Fat-free mass • Total body water • Intracellular fluid • Extracellular fluid • Skeletal muscle mass (SMM) • Skeletal muscle mass index (SMMI) The following outputs are also presented: • Body mass index (BMI) • Basal metabolic rate (BMR; based on Mifflin – St. Jeor’s algorithm) displayed in calories per day • Protein and mineral (also known as ‘dry lean mass’) represents the content of a body that is not fat or fluid; calculated by subtracting total body water weight from fat-free mass weight The MySOZO Software version 6.1.0.1 (SW Version 6.1.0.1) device measures current (I), voltage (V) and phase angle (Phi), and from these values calculates resistance (R), reactance (Xc), and impedance (Z), which are used to estimate the above body composition parameters. The device/software will also display the Cole plot, subject height, weight, age and sex.

Source page: https://510kreport.com/device/K260224
Methodology: https://510kreport.com/methodology