Cardiovascular · 510(k) · 2017
SOZO
ImpediMed Limited. Cleared by FDA on 11 August 2017 under submission K172122, product code OBH (monitor, extracellular fluid, lymphedema, extremity). What FDA's record says, in FDA's words.
Device record · K172122
- Device. SOZODEVICE
- Company. ImpediMed Limited (AU)COMPANY
- Decision. 11 August 2017, 510(k), substantially equivalent (special review); received 13 July 2017DECISION
- Panel. CardiovascularPANEL
- Product code. OBH, Monitor, Extracellular Fluid, Lymphedema, ExtremityCODE
- Regulation. 21 CFR 870.2770, Class IIREG
- Source. FDA database entry · decision document (7 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios of 4 that are displayed as an L -Dex ratio that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of unilateral lymphedema of the arm and leg in women and the leg in men. The device is only indicated for patients who will have or who have had lymph nodes, from the axillary and pelvic regions, either removed, damaged or irradiated. SOZOhub PC software – a PC software package that is intended to be used only with the ImpediMed SOZO device for uploading data on to the PC from the SOZO device, processing and analyzing of bioimpedance measurements.
The product code's definition, from FDA's classification record. Measure impedances in affected and unaffected but opposite extremity to periodically monitor the level of extracellular fluid or the differences in bioimpedance between opposing extremities for patients who have been previously diagnosed with unilateral lymphedema (that is, in one affected extremity)
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsmeasurement or quantification
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1 report filed against devices carrying product code OBH. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
13 August 2026 · Malfunction · SOZOapp · ImpediMed Limited · report 50233553
The SOZO was used to evaluate a patient for lymphedema. The patient demographics section in the SOZOapp was completed prior to patient arrival for efficiency of workflow. The patient's dominant hand must be entered on the demographics screen, however this information is not typically known until the patient arrives. As a workaround, the nurses enter Right for all patients and have to remember to go back to this screen if the patient is actually Left-handed once they arrive. In this case, the […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code OBH, in Cardiovascular, from ImpediMed Limited, or cleared in 2017. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.