Sozo Extracellular Fluid Monitor
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K172122 FDA 510(k)
- FDA Product Code
- OBH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2770 FDA 510(k)
- Regulation Number
- 870.2770 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sozo is an Extracellular Fluid Monitor for lymphedema, designed to measure and assess fluid accumulation in extremities. Classified under the nomenclature for monitoring extracellular fluid volume, it provides quantitative data to evaluate lymphedema progression or response to treatment in cardiovascular and related specialties.
Supplied as a reusable device, the Sozo operates in clinical or home settings and requires no sterilisation. It is classified as a Class II medical device under FDA and MDD regulations, with clearance via a 510(k) pathway (K172122) and registration numbers 3004782476, 3003857828, 3004896338, 3003695829, and 3005699942. Storage and use follow standard medical device protocols for non-invasive monitoring equipment.
Frequently asked questions
What clinical specialties would benefit most from using the Sozo Extracellular Fluid Monitor for lymphedema management?
The Sozo is primarily designed for use in cardiovascular and related specialties, where monitoring fluid accumulation in extremities—particularly for lymphedema—is critical. Clinicians in these fields can use the device to quantify fluid progression or treatment response, aiding in personalized care planning for patients with chronic fluid retention.
Is the Sozo intended for single-use or reusable applications, and what does that mean for maintenance?
The Sozo is explicitly reusable, meaning it is designed for repeated use in both clinical and home settings. Since it does not require sterilization, maintenance involves standard cleaning protocols for non-invasive monitoring equipment, ensuring hygiene and functionality between uses without the need for disposal after each session.
How does the Sozo differ from other lymphedema monitoring devices in terms of regulatory clearance?
The Sozo received FDA 510(k) clearance (K172122) under the Special 510(k) pathway, classified as a Class II device for monitoring extracellular fluid volume. This pathway was used because the device was deemed *substantially equivalent* to a predicate, ensuring its safety and performance meet regulatory standards for non-invasive fluid assessment without requiring invasive procedures.
What storage requirements should I follow for the Sozo to ensure optimal performance and longevity?
The Sozo follows standard medical device protocols for non-invasive monitoring equipment, meaning it should be stored in a clean, dry environment protected from extreme temperatures, moisture, or physical damage. Since it’s reusable and not sterile, avoid exposure to contaminants or direct sunlight, and adhere to manufacturer guidelines for calibration checks to maintain accuracy over time.
Can the Sozo be used in home settings, and if so, what considerations should patients or caregivers keep in mind?
Yes, the Sozo is approved for use in home settings as well as clinical environments. Patients or caregivers should ensure the device is placed correctly on the extremity (as per instructions) and kept clean between uses. Since it’s reusable and non-sterile, proper handling—like avoiding contact with water or harsh chemicals—is essential to preserve functionality and hygiene, especially for long-term monitoring.
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.
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 | K172122 | Class II | Active |
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Manufacturer
- Manufacturer
- Impedimed Limited
Sources (2)
- FDA 510(k) K172122 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026