SleepioRx

GUDID 00860008033024

SleepioRx is a digital therapeutic intended for the treatment of chronic insomnia / insomnia disorder as an adjunct to usual care in patients aged 18 and older. SleepioRx is a prescription device delivering Cognitive Behavioral Therapy for Insomnia (CBT-I) and can be made available on the order of a licensed healthcare provider.

Big Health Inc.

Mental health/function therapeutic software, screen-viewed

• Primary Device ID: 00860008033024
• NIH Device Record Key: 3b30cd30-60f1-49f1-b158-8023c265dc06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SleepioRx
• Version Model Number: v1
• Company DUNS: 079826953
• Company Name: Big Health 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: false
• 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

Customer Support Contacts

• Phone: (707) 563-1049
• Email: hello@bighealth.com
• Phone: (707) 563-1049
• Email: hello@bighealth.com
• Phone: (707) 563-1049
• Email: hello@bighealth.com
• Phone: (707) 563-1049
• Email: hello@bighealth.com
• Phone: (707) 563-1049
• Email: hello@bighealth.com
• Phone: (707) 563-1049
• Email: hello@bighealth.com
• Phone: (707) 563-1049
• Email: hello@bighealth.com
• Phone: (707) 563-1049
• Email: hello@bighealth.com
• Phone: (707) 563-1049
• Email: hello@bighealth.com
• Phone: (707) 563-1049
• Email: hello@bighealth.com
• Phone: (707) 563-1049
• Email: hello@bighealth.com
• Phone: (707) 563-1049
• Email: hello@bighealth.com
• Phone: (707) 563-1049
• Email: hello@bighealth.com
• Phone: (707) 563-1049
• Email: hello@bighealth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008033024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233577

FDA Product Code

• QVO: Computerized Behavioral Therapy Device For Insomnia

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: 2025-03-24
• Device Publish Date: 2025-03-14