510(k) K243146

iCare APP by Ihealth Labs, Inc. — Product Code MWI

K243146 is an FDA 510(k) premarket notification submitted by Ihealth Labs, Inc. for the device "iCare APP". The FDA issued a decision of Substantially Equivalent on February 3, 2025. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Ihealth Labs, Inc. has at least 3 other 510(k) clearances on record.