NightWatch+ US

Primary DI
08719327236086
Brand
NightWatch+ US
Company
Livassured B.V.
Model
1.0
Device description
The NightWatch+ US is a prescription only device that is indicated for use as an adjunct to seizure monitoring of children age 4 till 16 diagnosed with epilepsy having Nocturnal Epileptic Major Motor Seizures which includes tonic-clonic (TC), tonic (if clustered or prolonged >30 seconds), hyperkinetic and TC-like seizures, in home or residential facilities during periods of rest. NightWatch+ US consists of a sensor worn during sleep on the biceps of the upper arm and an alarm station. The sensor consists of a heartrate sensor using PPG (photoplethysmography), a ACC (Accelerometry) movement sensor, and a microprocessor. The microprocessor processes the data from the sensors using a detection algorithm which detects if the sensor readings match pre-programmed parameters that are associated with nocturnal epileptic major motor seizures. When a nocturnal epileptic major motor seizures is detected, the seizure alarm is triggered and transferred from the sensor to the accompanying alarm station which alarms the caregiver by a sound and a blinking LED light. The seizure alarms data can be transferred from the alarm station, using an ethernet connection, to a database in the cloud to be viewed a web-based interface called NightWatch Portal to be able to monitor seizure frequency overtime.The NightWatch+ US is not intended to diagnose specific seizure types.
Published
2026-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
POSPhysiological Signal Based Seizure Monitoring System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POSPhysiological Signal Based Seizure Monitoring SystemNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243199000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243199000NightWatch+ USLivassured BV2025-07-12POS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719327236086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719327236086087193272360868719327236086

GMDN Terms#

Term, Definition table
TermDefinition
Home seizure monitoring systemAn assembly of devices intended to detect and record a seizure by continuous measurement of one or more physical/physiological parameters (e.g., body motion, electrical activity of the heart or skeletal muscles) in a patient with epilepsy during daily activities and/or sleep in the home; some types may also be used in clinical settings. It typically consists of a mains electricity (AC-powered) central monitor that wirelessly receives, records, and displays the data, and one or more battery-powered body-worn sensor(s); it may have alarms and data may be transmitted to a cloud-based storage, server or mobile device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9999999999Contact-us@nightwatchepilepsy.com

Regulatory Flags#

DUNS number
491013254
Device count
1
Serial number
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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B481SPC15900441SPEAC System Electrode Patch SPC15-90044, EUBRAIN SENTINEL, INC.POS2019-08-26
B481SPC15900451SPEAC System Electrode Patch-SPC15-90045, EUBRAIN SENTINEL, INC.POS2019-08-26
B481SPC15900181SPEAC System Electrode Patch SPC15-90018BRAIN SENTINEL, INC.POS2019-08-13
B481SPC15900431SPEAC System Electrode Patch-SPC15-900431BRAIN SENTINEL, INC.POS2019-08-13
B481SPC15900571SPEAC System Assy, Mini Monitor, USBRAIN SENTINEL, INC.POS2019-08-13
08538580061026Embrace2EMPATICA SRLPOS2018-11-09
08538580061194Embrace2EMPATICA SRLPOS2018-11-09
08538580061262Embrace2EMPATICA SRLPOS2018-11-09
08538580061330Embrace2EMPATICA SRLPOS2018-11-09
08538580061408Embrace2EMPATICA SRLPOS2018-11-09
B481SPC150SPEAC SystemBRAIN SENTINEL, INC.POS2017-09-01