Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
K-Number: K242737 · 2025-06-06
ApplicantEmpatica S.r.l.
Decision Date2025-06-06
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal is a medical device manufactured by Empatica S.r.l.. It received FDA 510(k) clearance on 2025-06-06 under approval number K242737. 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 Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal?
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal is a medical device that received FDA 510(k) clearance on 2025-06-06. It is manufactured by Empatica S.r.l.. The 510(k) number is K242737.
When was Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal approved by the FDA?
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal received FDA 510(k) clearance on 2025-06-06, under approval number K242737.
What company makes Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal?
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal is manufactured by Empatica S.r.l..
What is the FDA product code for Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal?
The FDA product code for Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal is MWI.
Related Clinical Trials
NCT07614581
Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study
NOT_YET_RECRUITING
NCT07124247
Implementation of the MOX Activity Monitor in Hospitalized Geriatric Rehabilitation
COMPLETED
NCT06888687
Comparison of Dietetics Support With and Without Continuous Glucose Monitoring in Individuals With Type 2 Diabetes.
ACTIVE_NOT_RECRUITING
NCT07602036
Type 2 Diabetes and Pregnancy a Single-arm Interventional Study
NOT_YET_RECRUITING
NCT06750549
Mobile Application for Patient Engagement and Physician-Directed Remote Management of Heart Failure
COMPLETED
NCT06159595
Behavioral and Neuronal Correlates of Human Mood States
COMPLETED
Related PubMed Literature
PMID: 41790854
A Substance Use Disorder Virtual Treatment and Research Platform: A Proof of Concept.
IEEE pulse (2025)
PMID: 41595987
Recent Advances in AI-Driven Mobile Health Enhancing Healthcare-Narrative Insights into Latest Progress.
Bioengineering (Basel, Switzerland) (2025)
PMID: 41488933
A narrative review on the environmental impact of medicines: from water analysis and
Frontiers in drug safety and regulation (2025)
PMID: 40040264
Hospital medical device quality and safety monitoring using real-world data from Friuli Venezia Giulia regional health coordination agency.
Expert review of medical devices (2025)
Other Devices by Empatica S.r.l.
Related Devices (Code: MWI)
K161909IQvitals ZoneMidmark Corporation
K160718Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien
K151839AMC Health VitalCaregiving SystemAmc Health
K160956LD-Oxi systemLd Technology, LLC
K153739MRI Patient Monitor TeslaDUOMipm Mammendorfer Institut Fur Physik Und Medizin
K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation
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.