Neurology · 510(k) · 2025
Nelli (Version 7.11)
Neuro Event Labs OY. Cleared by FDA on 21 November 2025 under submission K251506, product code POS (physiological signal based seizure monitoring system). What FDA's record says, in FDA's words.
Device record · K251506
- Device. Nelli (Version 7.11)DEVICE
- Company. Neuro Event Labs OY (FI)COMPANY
- Decision. 21 November 2025, 510(k), substantially equivalent (traditional review); received 16 May 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 (10 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.
Please type in the marketing application/submission number, if it is known. This K251506 ? textbox will be left blank for original applications/submissions. Please provide the device trade name(s). ? Nelli (Version 7.11) Please provide your Indications for Use below. ? Nelli is indicated for use as an adjunct to seizure monitoring of patients aged 18 years and above in healthcare facilities during periods of rest. The device utilizes automated analysis of audio and video (media) to identify epileptic and non-epileptic seizure events with a positive motor component. The system provides prioritization of identified major seizures and other motor events for review and media playback by a qualified healthcare professional. Please select the types of uses (select one or both, as � Prescription Use (Part 21 CFR 801 Subpart D) applicable). D Over-The-Counter Use (21 CFR 801 Subpart C) ? Submitter Contact Details Preparation Date: 2025-11-20 Applicant Name: Neuro Event Labs Oy Applicant Address: Biokatu 10, 33520 Tampere, FINLAND Applicant Contact Name: Pierre Pelletier Applicant Contact Telephone: +358 50 303 5269 Applicant Contact Email: [email protected] Device Identification Device Trade Name: Nelli Common Name: Seizure monitoring system Classification Name: Non-electroencephalogram (EEG) physiological signal based seizure monitoring system Regulation Number: 21 CFR §882.1580 Product […]
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
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsprescription use
- Mentionsadult 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, 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.