# K243146: iCare APP

- Pathway: 510(k) (Traditional)
- Applicant: Ihealth Labs, Inc.
- Decided: Feb 3, 2025 after 126 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K181541 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181541: Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK, Andon Health Co, Ltd. (2019) Summary page 5.

## Indications for use
The iCare App is intended for use in the home and clinical settings as an aid for users and their healthcare professionals to view test results which are measured by iHealth devices to better manage user's health and get feedback from their professional care team. The iCare App can also connect to medical devices and/or non-medical devices and get data from devices during measurement or from the data stored in memory of the device for enhanced data managements. Data can be transmitted, displayed, and stored in the App.

Source page: https://510kreport.com/device/K243146
Methodology: https://510kreport.com/methodology