Cleared Traditional

iCare APP

K243146 · Ihealth Labs, Inc. · Cardiovascular

Feb 2025

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K243146 is an FDA 510(k) clearance for the iCare APP, a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by Ihealth Labs, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 3, 2025, 126 days after receiving the submission on September 30, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K243146 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2024
Decision Date	February 03, 2025
Days to Decision	126 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2300