510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190529Substantially Equivalent

Sozo

Impedimed, Inc., Pinkenba, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190529 is the FDA 510(k) clearance record for SOZO, a class II device, cleared for ImpediMed Limited on under FDA product code QJB (Adjunct Monitor, Protein Calorie Malnutrition). FDA's definition for product code QJB reads: "Device applies an alternating current of one specified frequency or more through skin-surface electrodes to estimate one or more the body composition parameters". FDA records list 16 510(k) clearances for ImpediMed Limited, from to . As of , FDA records show no recalls naming K190529.

Clearance record

Decision date
Received
(266 days to decision)
Product code
QJB Adjunct Monitor, Protein Calorie Malnutrition
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Applicant
ImpediMed Limited Unit 1, 50 Parker Ct., Pinkenba, AU
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QJB

Trailing 12 months

FDA records hold no clearances under product code QJB in the trailing twelve months.

FDA records show no clearances under product code QJB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QJB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260