FDA.reportPublic FDA data

510(k) K243146

Device
iCare APP
Applicant
Ihealth Labs, Inc.
510(k) number
K243146
Product code
MWI
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-03
Date received
2024-09-30
Regulation
870.2300
Classification name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Tianyang Liu
Address
880 W Maude Ave., Sunnyvale CA US 94085 94085

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MWI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253436c-med0 alphaCosinuss GmbH2026-04-30
K250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel Medical2026-01-16
K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV2025-08-27
K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.2025-06-06
K241958WARD-CSS (v1.2.x)Ward 24/7 Aps2025-02-14
K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.2024-12-20
K243216Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)Analog Devices2024-12-10
K233446AMC Health CareConsoleAmc Health2024-09-27
K240236Happy Ring Health Monitoring SystemHappy Health, Inc.2024-09-24
K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.2024-06-26
K232111NeoBeat, NeoBeat MiniLaerdal Medical AS2024-06-25
K233810Portrait VSMGe Medical Systems Information Technologies, Inc.2024-04-25
K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC2024-04-01
K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse OGe Medical Systems Information Technologies, Inc.2024-03-20
K233038Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc.2024-03-08