Sozo

The SOZO is designed for clinical use in cardiovascular and lymphatic care settings. This is because it specializes in non-invasive bioimpedance spectroscopy to assess extracellular fluid and tissue composition, particularly for monitoring lymphedema in extremities—a condition commonly managed in these specialties. Its rapid measurement capability (under 30 seconds) makes it practical for routine monitoring in outpatient clinics, rehabilitation centers, or specialized cardiovascular/lymphatic clinics.

The SOZO is a reusable medical instrument, meaning it is not intended for single-use. This design eliminates the need for sterile packaging or disposal after each use, reducing waste and potentially lowering long-term costs. However, it requires proper cleaning and maintenance protocols to ensure accuracy and longevity, unlike single-use devices that are discarded after one use. The reusable nature also allows for consistent calibration and updates across multiple patient assessments.

The SOZO received FDA clearance through a 510(k) Traditional Review process, specifically under the Cardiovascular (CV) Advisory Committee, with a clearance number of K180126. This means the device was deemed substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for monitoring extracellular fluid and lymphedema in extremities. Clinicians can trust its regulatory validation, as it aligns with FDA’s classification under regulation number 870.2770 for such monitors.

The SOZO is associated with four registration numbers (3004782476, 3003857828, 3004896338, 3003695829, and 3005699942) under the Extracellular Fluid Monitor, Lymphedema, Extremity product code (OBH). While the exact variations aren’t detailed, these registrations suggest potential adaptations for different extremity sizes or patient populations (e.g., pediatric vs. adult). Clinicians should confirm with the manufacturer whether specific electrode sizes or configurations are available to ensure accurate measurements across diverse patient anatomies.

The SOZO’s non-invasive bioimpedance spectroscopy approach eliminates the need for needles, incisions, or invasive procedures, which can significantly improve patient comfort—especially for those with lymphedema or sensitive skin. Clinically, this also streamlines workflows by reducing preparation time (e.g., no venipuncture or catheterization) and enabling rapid measurements (under 30 seconds per assessment). The reusable design further enhances efficiency by avoiding the setup and disposal steps required for single-use devices.