Data / Medical devices / Italy / EMPATICA S.r.l.

EMPATICA S.r.l.: FDA-registered device maker in Milano, Italy, 10 510(k) clearances

Name: EMPATICA S.r.l. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

EMPATICA S.r.l. is registered with the FDA (registration 3012933969) in Milano, Italy. It lists 11 device types. The FDA files 10 510(k) clearances under its listings, the newest dated August 14, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch EMPATICA S.r.l.

FDA registration number: 3012933969
Address: Via Enrico Stendhal 36, Milano, Italy, 20144
Owner or operator: Empatica (10058838)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: November 2, 2018
Registered through: 2026
Brand names listed: Care Portal, EmbraceMini, EmbracePlus, Empatica Care, Empatica Health Monitoring Platform, Empatica Health Monitoring Platform for Parkinson's Disease Monitoring, EpiMonitor, PKG Monitor by Empatica and more

Devices it lists

Device	Product code	Class	Role	Source
Continuous Measurement Thermometer	FLL	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Device, Galvanic Skin Response Measurement	GZO	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Device, Sleep Assessment	LEL	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Exerciser, Measuring	ISD	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Monitor, Breathing Frequency	BZQ	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Oximeter	DQA	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Physiological Signal Based Seizure Monitoring System	POS	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Reminder, Medication	NXQ	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Transducer, Tremor	GYD	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Transmitters And Receivers, Physiological Signal, Radiofrequency	DRG	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 14, 2026	K260374	Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal	GYD	Substantially Equivalent	Empatica S.r.l.	accessdata.fda.gov
December 22, 2025	K252981	EmbraceMini	LEL	Substantially Equivalent	Empatica S.r.l.	accessdata.fda.gov
June 19, 2025	K250515	EpiMonitor	POS	Substantially Equivalent	Empatica S.r.l.	accessdata.fda.gov
June 6, 2025	K242737	Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal	MWI	Substantially Equivalent	Empatica S.r.l.	accessdata.fda.gov
February 15, 2024	K232915	EpiMonitor	POS	Substantially Equivalent	Empatica S.r.l.	accessdata.fda.gov
October 30, 2023	K230457	Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal	MWI	Substantially Equivalent	Empatica S.r.l.	accessdata.fda.gov
November 20, 2022	K221282	Empatica Health Monitoring Platform	DQA	Substantially Equivalent	Empatica S.r.l.	accessdata.fda.gov
March 11, 2022	K211887	Personal Kinetigraph (PKG) System Gen 2 Plus	GYD	Substantially Equivalent	Gkc Manufacturing Pty, Ltd.	accessdata.fda.gov
December 20, 2018	K181861	Embrace	POS	Substantially Equivalent	Empatica S.r.l.	accessdata.fda.gov
January 26, 2018	K172935	Embrace	POS	Substantially Equivalent	Empatica S.r.l.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 13, 2023	93215	Class II	Ongoing	Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3)	May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.	accessdata.fda.gov

Compare with other makers

Updated August 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.