EpiWatch

Basic Information

• Brand Name: EpiWatch
• Primary DI: 00860013047702
• Version / Model: 1
• Company Name: Epiwatch, Inc.
• Labeler DUNS: 118597858
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-20
• Public Version: 1
• Public Version Date: 2026-03-30
• Public Version Status: New
• Public Device Record Key: bca251cc-22eb-4860-bcad-b0eb91302fb4
• Distribution End Date: 2030-12-31

Device Description

Seizure detection algorithm app for tonic clonic seizure detection, alerting and monitoring

Device Characteristics

• Single Use: Yes
• 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: No
• 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
61087	Clinical management support software	An application software program intended to facilitate clinical management decisions by receiving patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic/laboratory results) and returning clinical care information (e.g., reports, referral pathways, pedigree diagrams, reminders, post-therapy prognosis/risk score, anaesthesia/pharmaceutical dosage, and/or links to guidelines) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. Also known as clinical decision support (CDS) software, it may be a locally-installed program, web-based, or mobile application.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860013047702	GS1

Premarket Submissions

Submission Number	Supplement Number
K243515	000