Cardiovascular · 510(k) · 2019
SOZO
ImpediMed Limited. Cleared by FDA on 25 November 2019 under submission K190529, product code QJB (adjunct monitor, protein calorie malnutrition). What FDA's record says, in FDA's words.
Device record · K190529
- Device. SOZODEVICE
- Company. ImpediMed Limited (AU)COMPANY
- Decision. 25 November 2019, 510(k), substantially equivalent (traditional review); received 4 March 2019DECISION
- Panel. CardiovascularPANEL
- Product code. QJB, Adjunct Monitor, Protein Calorie MalnutritionCODE
- 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.
The SOZO system may be used as an adjunct to existing methods by aiding clinicians who are using Subjective Global Assessment (SGA) tools to assess patients at risk of protein-calorie malnutrition (PCM). The SOZO system may be further used to estimate the following body composition parameters in humans to track
The product code's definition, from FDA's classification record. Device applies an alternating current of one specified frequency or more through skin-surface electrodes to estimate one or more the body composition parameters.
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.
- Mentionsan adjunct to the clinician, not a replacement
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1 report filed against devices carrying product code QJB. 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:
31 May 2024 · Malfunction · DEXCOM G7 SENSOR · DEXCOM, INC. · report MW5155667
I HAVE HAD 3 SENSORS. THE FIRST ONE GLUED ITSELF TO MY SWEATER. FIRST DAY I PUT IT ON. THE SECOND ONE I GOT GAVE ERRATIC READINGS. AFTER A CALIBRATION IT KEPT LOSING ITS SIGNAL. THE THIRD ONE QUIT WORKING AFTER 8 DAYS. AS MUCH AS THE THIRD ONE SEEMED TO MOSTLY GIVE FAIRLY ACCURATE READINGS I DID GET A FEW THAT WERE NO WHERE NEAR WHERE THEY SHOULD HAVE BEEN. REFERENCE REPORTS: MW5155666, MW5155668.
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 QJB, in Cardiovascular, from ImpediMed Limited, or cleared in 2019. 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.