iCare APP
K-Number: K243146 · 2025-02-03
ApplicantIhealth Labs, Inc.
Decision Date2025-02-03
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
iCare APP is a medical device manufactured by Ihealth Labs, Inc.. It received FDA 510(k) clearance on 2025-02-03 under approval number K243146. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the iCare APP?
iCare APP is a medical device that received FDA 510(k) clearance on 2025-02-03. It is manufactured by Ihealth Labs, Inc.. The 510(k) number is K243146.
When was iCare APP approved by the FDA?
iCare APP received FDA 510(k) clearance on 2025-02-03, under approval number K243146.
What company makes iCare APP?
iCare APP is manufactured by Ihealth Labs, Inc..
What is the FDA product code for iCare APP?
The FDA product code for iCare APP is MWI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.