NightWatch+ US

Basic Information

• Brand Name: NightWatch+ US
• Primary DI: 08719327236086
• Version / Model: 1.0
• Company Name: Livassured B.V.
• Labeler DUNS: 491013254
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-06
• Public Version: 1
• Public Version Date: 2026-01-14
• Public Version Status: New
• Public Device Record Key: 488653a3-5ec4-4eab-865c-b7d6bb80d715

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
POS	Physiological Signal Based Seizure Monitoring System	Neurology	882.1580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61288	Home seizure monitoring system	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08719327236086	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K243199	000