EpiWatch

GUDID 00860013047702

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

Epiwatch, Inc.

Clinical management support software

• Primary Device ID: 00860013047702
• NIH Device Record Key: bca251cc-22eb-4860-bcad-b0eb91302fb4
• Commercial Distribution Discontinuation: 2030-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EpiWatch
• Version Model Number: 1
• Company DUNS: 118597858
• Company Name: Epiwatch, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013047702 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243515

FDA Product Code

• POS: Physiological Signal Based Seizure Monitoring System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-30
• Device Publish Date: 2026-03-20