DeviceClearance

Product code QJB— Cardiovascular

SOZO

Classification name
Adjunct Monitor, Protein Calorie Malnutrition
Device class
Class 2
Regulation
21 CFR 870.2770
Advisory panel
Cardiovascular
Total cleared
2
First cleared
Most recent

FDA classification definition

“Device applies an alternating current of one specified frequency or more through skin-surface electrodes to estimate one or more the body composition parameters.”

— U.S. Food and Drug Administration, device classification record for product code QJB under 21 CFR 870.2770, via openFDA

Market context for product code QJB

FDA has cleared 2 devices under product code QJB between 2019 and 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QJB

Recent clearances under product code QJB

Data sourced from openFDA. This site is unofficial and independent of the FDA.