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FDA 510(k)

Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal

K-Number: K260374 · 2026-08-14

ApplicantEmpatica S.r.l.
Decision Date2026-08-14
Product CodeGYD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal is the device name listed in this FDA 510(k) record. The listed applicant is Empatica S.r.l.. It received FDA 510(k) clearance on 2026-08-14 under 510(k) number K260374. The device is classified under product code GYD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal?

Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal is a medical device that received FDA 510(k) clearance on 2026-08-14. The listed applicant is Empatica S.r.l.. The 510(k) number is K260374.

When did Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal receive FDA 510(k) clearance?

Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal received FDA 510(k) clearance on 2026-08-14, under 510(k) number K260374.

Who is the listed applicant for Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal?

The FDA 510(k) record lists Empatica S.r.l. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal?

The FDA product code for Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal is GYD.

Related Clinical Trials

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Other records listing Empatica S.r.l. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252981EmbraceMiniK250515EpiMonitorK242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalK232915EpiMonitorK230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalK221282Empatica Health Monitoring Platform

View all 9 devices →

Related Devices (Code: GYD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253055Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)Nordic Kinetics ABK250153Neu PlatformNeuhealth Digital , Ltd.K221772NeuroRPMNew Touch Digital, Inc.K220820Parky AppH2o Bilisim YazilimK213519Rune Labs Tremor Transducer SystemRune Labs, Inc.K211887Personal Kinetigraph (PKG) System Gen 2 PlusGkc Manufacturing Pty, Ltd.

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.

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