Class Class II
iCare APP (K243146)
Description
iCare APP by Ihealth Labs, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243146
Clearance Date2025-02-03
Clearance TypeTraditional
Product CodeMWI
Regulation Number870.2300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243146
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. iCare APP (K243146) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K181541 | Connect App for iHealth Next, iHealth React Native SDK, iHe... | Andon Health Co, Ltd. | 2019 |
Trace the full predicate network for K243146
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.