# K232089: SOZO Pro

- Pathway: 510(k) (Traditional)
- Applicant: ImpediMed Limited
- Decided: Oct 17, 2023 after 96 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: 9 generations back to K922218 (1992). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203473: SOZO, ImpediMed Limited (2021) Summary page 6.

## Most influential descendants
- K260224: MySOZO Software version 6.1.0.1 (SW version 6.1.0.1) (2026), 0 descendants of its own
- K253224: MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) (2026), 0 descendants of its own

## Indications for use
The SOZO Pro has the following uses: 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 extracel lular volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical as sessment of lym phedema. The use ofthe 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 iradiated. The SOZO Pro 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 managem ent problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data. The SOZO Pro may be used as an adjunct to existing methods by aiding clinicians who are using Subj ective Global Assessment (SGA) tools to assess patients at risk of protein-calorie malnutrition (PCM). The SOZO Pro 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-free mass * Total body water * Intracellular fluid * Extracellular fluid ¢ Skeletal muscle mass The following outputs are also presented: * Body Mass Index (BMI) * Basal metabolic rate (BMR; based on Mifflin — St. Jeor’s algorithm ) dis played 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; cal culated by subtracting total body water weight from fat-free mass weight. The SOZO Pro 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/K232089
Methodology: https://510kreport.com/methodology