Neurology · 510(k) · 2025
EpiMonitor
Empatica Srl. Cleared by FDA on 19 June 2025 under submission K250515, product code POS (physiological signal based seizure monitoring system). What FDA's record says, in FDA's words.
Device record · K250515
- Device. EpiMonitorDEVICE
- Company. Empatica Srl (IT)COMPANY
- Decision. 19 June 2025, 510(k), substantially equivalent (special review); received 21 February 2025DECISION
- Panel. NeurologyPANEL
- Product code. POS, Physiological Signal Based Seizure Monitoring SystemCODE
- Regulation. 21 CFR 882.1580, Class IIREG
- Source. FDA database entry · decision document (14 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
EpiMonitor is a prescription only medical device system composed of a wearable device “EmbracePlus” and paired mobile software application “EpiMonitor” intended as an adjunct to seizure monitoring in adults and children aged 6 and up in a home environment or healthcare facilities. The device is worn on the wrist and senses Electrodermal Activity (EDA) and motion data to detect patterns that may be associated with either primary or secondary generalized tonic clonic seizures in patients with epilepsy or at risk of having epilepsy. When a seizure event is detected, the wearable device component of EpiMonitor sends a command to a paired mobile device where the EpiMonitor App is programmed to initiate an alert to a designated caregiver. The EpiMonitor app incorporates additional detection sensitivity modes, "high" for use during periods of rest or sleeping or "low" for use during periods of low-intensity activity, in order to reduce false alarm incidents. EpiMonitor records, stores and transmits accelerometers, EDA, Peripheral skin temperature and activity data for subsequent retrospective review by a trained healthcare professional via a cloud-based software.
The product code's definition, from FDA's classification record. The Physiological signal based seizure monitoring system is a prescription device that uses physiological signal to identify abnormal physiological activity that may be associated with a seizure. The System does not predict seizure onsets, and is not intended as a standalone seizure monitoring device.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
- Mentionsadult patients
- Mentionspediatric patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 4 reports filed against devices carrying product code POS. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
22 April 2026 · Injury · EMBRACE2 · EMPATICA S. R. L. · report MW5187195
THE SEIZURE ALERT STOPPED WORKING, APP ON CELL PHONE WOULD OPEN THEN IMMEDIATELY SHUT DOWN. I WENT TO LOG IN AND IT REJECTED LOGIN STATING "REVOKED". IT WANTED ME TO CONTACT THEM. THEIR PHONE SYSTEM NEVER GIVES YOU A HUMAN BEING JUST AN ANSWERING MACHINE. I LEFT A MESSAGE AND THEN SENT A EMAIL. THEIR RESPONSE STATED A"48 HOUR RESPONSE" TIME. BASICALLY FOR 48 HOURS THIS SEIZURE MONITORING DEVICE CALLED EMBRACE2 WILL NOT ALERT CARE PROVIDERS SHOULD I HAVE A MEDICAL EMERGENCY. THE SAME DAY IN THE […]
10 December 2025 · Malfunction · UMBILICAL CATHETER 3.5F · UTAH MEDICAL PRODUCTS, INC. · report MW5180234
SINGLE-LUMEN SILICONE UMBILICAL CATHETER 3.5FR PLACED IN THE PATIENT. FAULTY CATHETER NOTED, DISTAL END OF CATHETER LOOSE, UNABLE TO TIGHTEN TO STOPCOK COMPLETELY. UNABLE TO GET AN ACCURATE BLOOD PRESSURE READING WITH TRANSDUCER CABLE. LINE TROUBLE SHOOTED, ULTIMATELY DETERMINED THAT CATHETER PIECE WAS FAULTY. CATHETER REMOVED, INSERTED NEW UMBILICAL LINE CATHETER-USED A DIFFERENT BRAND/PRODUCT.
16 February 2024 · Malfunction · EMBRACE2 WATCH · EMPATICA S.R.L. · report MW5151782
I HAVE AN EMPATICA EMBRACE2 SEIZURE DETECTION WATCH WHICH SENDS ALERTS (VIA AN APP ON MY PHONE) TO DESIGNATED CONTACTS IF IT DETECTS A SEIZURE MAY BE HAPPENING. THERE IS A 15 SECOND TIMEFRAME FOR ME TO CANCEL THE ALERT BEING SENT FROM MY PHONE IF ITS S 'FALSE ALARM'. ON (B)(6) 2024, AT 17:30, IT DETECTED A POSSIBLE SEIZURE AND THE APP MESSAGE APPEARED ON MY PHONE AS ALERT SENT TO MY CONTACT HOWEVER MY CONTACT DIDN'T RECEIVE THE ALERT UNTIL 17:57. IN THIS INSTANCE IT WAS A FALSE ALARM THAT I […]
13 October 2021 · Injury · EMBRACE2 · EMPATICA S. R. L. · report MW5104600
MY SEIZURE DETECTION WATCH, AN FDA APPROVED DEVICE FAILED TO ALERT DURING A SEIZURE. THE ERROR REPORTED ON MY PHONE WAS 'SERVER ERROR, ALERT NOT SENT'. NOBODY KNEW I HAD A SEIZURE. THE APP OBVIOUSLY KNEW I HAD A SEIZURE AND TRIED TO REPORT IT, BUT THERE WAS A MALFUNCTION ON EMPATICAS SIDE. FDA SAFETY REPORT ID # (B)(4).
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code POS, in Neurology, from Empatica Srl, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.