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Sozo

by Impedimed Limited

510(k) K190529Ref 2726695Model SOZO

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K190529↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-B2772726995SR Basic UDI-DI B2772726995SRUDI-DIDate9 Jan 2025RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK190529 Date25 Nov 2019ClearedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-B2772726995SR registered 9 Jan 2025 Active
  • FDA 510(k) K190529 decided 25 Nov 2019 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K190529
  2. Registered EUDAMED B-B2772726995SR

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Model / reference
SOZO, 2726695
Primary DI / UDI-DI
B2772726995SR
Basic UDI-DI
B-B2772726995SR
510(k) Number
FDA product code
QJB
EMDN code
Z12099001 Body impedance analysers
Device class
Class IIa EUDAMED
Class II 510(k)
Regulation
21 CFR Part 870.2770
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Denmark
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device classEUDAMED
Class IIa
510(k)
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA 510(k)). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

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Properties

  • Measuring function
Other properties (11, all answered No)