ImpediMed Limited · Class II · Cleared Jan 28, 2026
| K-number | K253224 |
| Device name | MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) |
| Applicant | ImpediMed Limited |
| Product code | OBH |
| Device class | Class II |
| Decision date | Jan 28, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.2770 |
MySOZO Software version 6.0.1.2 is cloud-based software that enables bioimpedance spectroscopy measurements using SOZO or SOZO Pro devices. It measures patient fluid status for heart failure monitoring, lymphedema assessment via L-Dex ratio, protein-calorie malnutrition screening, and body composition estimation (fat mass, muscle mass, total body water, etc.). The software applies small electrical currents across 256 frequencies and calculates impedance values to estimate these parameters.
MySOZO Software version 6.0.1.2 uses the same bioimpedance spectroscopy principle as its predicate. Data is stored in a cloud-based database accessed via web browser; SOZO/SOZO Pro devices connect via Bluetooth to an iOS/Android tablet app over Wi-Fi. Version 6.0 updated the user interface; version 6.0.1 reinforced Bluetooth connectivity; version 6.0.1.2 updated the bilateral L-Dex assessment module. All versions use the same 200μA RMS electrical energy application across identical frequency ranges.
Not stated in this summary.
MySOZO Software version 6.0.1.2 has identical intended use, indications for use, principles of operation, and technological characteristics as its predicate SOZO Pro (K232089). The design updates (UI alignment, Bluetooth hardening, L-Dex bilateral assessment module) do not raise new safety or effectiveness questions. Verification and validation testing confirmed the software performs as intended.
View the full FDA submission: accessdata.fda.gov