Sozo
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- SOZO EUDAMED
- Device Name
- SOZO Digital Health Platform EUDAMED
- Model / Reference
- SOZO EUDAMED2726695 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B2772726995SR EUDAMED
- Basic UDI-DI
- B-B2772726995SR EUDAMED
- 510(k) Number
- K190529 FDA 510(k)
- FDA Product Code
- QJB FDA 510(k)
- EMDN Code
- Z12099001 BODY IMPEDANCE ANALYSERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2770 FDA 510(k)
- Regulation Number
- 870.2770 FDA 510(k)
- Market of Registration
- Denmark EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
The SOZO Digital Health Platform is a non-invasive bioimpedance spectroscopy (BIS) device designed for assessing fluid status and tissue composition. Classified as an adjunct monitor for protein-calorie malnutrition, it employs L-Dex technology to evaluate lymphedema and other fluid-related conditions in both healthy and clinical populations. By analyzing impedance across multiple frequencies, it provides quantitative insights into extracellular and intracellular water distribution, aiding in personalized patient monitoring.
This device is supplied as a single-use or reusable system (depending on component configuration) and is not MRI-safe. It operates in clinical and research settings, including cardiovascular and general medical environments. Sterility is maintained through manufacturer-provided protocols, and the device is regulated under FDA 510(k) clearance (K190529, QJB) and MDD compliance. Storage requirements and usage instructions are detailed in the accompanying technical documentation.
Frequently asked questions
What clinical conditions can the SOZO device help assess using its L-Dex technology?
The SOZO device uses L-Dex bioimpedance spectroscopy to evaluate fluid-related conditions, including lymphedema and protein-calorie malnutrition. It quantifies extracellular and intracellular water distribution, helping clinicians monitor fluid status and tissue composition in both clinical and research settings, such as cardiovascular and general medical environments.
Is the SOZO device single-use or reusable, and how does sterility work?
The SOZO device can be supplied as either single-use or reusable, depending on the specific component configuration chosen. Sterility is maintained through manufacturer-provided protocols, which must be followed to ensure proper use and contamination control.
What types of environments is the SOZO device intended for, and what are its limitations?
The SOZO device is designed for use in clinical and research settings, particularly in cardiovascular and general medical environments. However, it is not MRI-safe, meaning it cannot be used in magnetic resonance imaging environments. Its primary purpose is as an adjunct monitor for assessing fluid status and tissue composition.
How is the SOZO device regulated, and what does that mean for its use?
The SOZO device holds FDA 510(k) clearance (K190529, QJB) and complies with the Medical Device Directive (MDD). This means it has undergone regulatory review to demonstrate substantial equivalence to a predicate device and meets EU safety and performance standards. Clinicians and buyers can rely on this regulatory pathway for its intended use as an adjunct monitor for fluid status assessment.
Where can I find detailed instructions on storage and proper usage of the SOZO device?
The SOZO device’s storage requirements and usage instructions are outlined in the accompanying technical documentation provided by the manufacturer. This documentation ensures proper handling, maintenance, and operation to maximize performance and safety.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SOZO® Digital Health Platform | ImpediMed, Medical Bioimpedance Spectroscopy (BIS) Devices | ImpediMed, Impedimed Sozo | Health Techonology | Sandbourne Medical, ImpediMed Limited (IPD) - SOZO is the go - ords.com.au
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K190529 | Class II | Active |
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Manufacturer
- Manufacturer
- Impedimed Limited
Sources (2)
- FDA 510(k) K190529 24 fields · synced Sep 20, 2026
- EUDAMED 46ca7b81-8522-4ea7-b20e-759cc037b697 61 fields · synced Jul 21, 2026