Regulora® 60005-97020

GUDID 00860005970209

Regulora® is prescription-only digital therapeutic (PDT) software indicated for use in the treatment of abdominal pain due to Irritable Bowel Syndrome (IBS). The Regulora program is Software as a Medical Device (SaMD) that resides on and is accessed through the user’s mobile device and can be executed at home. Regulora digitizes scripted therapist-administered gut-directed psychotherapy and provides 7 unique treatment sessions, each lasting ~30 minutes, every other week over 12 weeks. The treatment sessions are designed to first induce deep physical and autonomic relaxation which is followed by metaphorical storytelling and a combination of direct and indirect suggestions targeted at somatic control mechanisms. Regulora also provides for IBS symptom tracking, which patients can share with their doctor in the management of their IBS.

Metame Health, Inc.

Mindfulness/behavioural therapy software, non-clinician-consultative Mindfulness/behavioural therapy software, non-clinician-consultative Mindfulness/behavioural therapy software, non-clinician-consultative Mindfulness/behavioural therapy software, non-clinician-consultative Mindfulness/behavioural therapy software, non-clinician-consultative Mindfulness/behavioural therapy software, non-clinician-consultative Mindfulness/behavioural therapy software, non-clinician-consultative Mindfulness/behavioural therapy software, non-clinician-consultative Mindfulness/behavioural therapy software, non-clinician-consultative Mindfulness/behavioural therapy software, non-clinician-consultative Mindfulness/behavioural therapy software, non-clinician-consultative

• Primary Device ID: 00860005970209
• NIH Device Record Key: 77eb2ff6-85ed-426e-93c8-249160d86afa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Regulora®
• Version Model Number: GDH-1
• Catalog Number: 60005-97020
• Company DUNS: 080168265
• Company Name: Metame 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: true
• Serial Number: false
• Manufacturing Date: true
• 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: 888-463-8263
• Email: info@metamehealth.com
• Phone: 888-463-8263
• Email: info@metamehealth.com
• Phone: 888-463-8263
• Email: info@metamehealth.com
• Phone: 888-463-8263
• Email: info@metamehealth.com
• Phone: 888-463-8263
• Email: info@metamehealth.com
• Phone: 888-463-8263
• Email: info@metamehealth.com
• Phone: 888-463-8263
• Email: info@metamehealth.com
• Phone: 888-463-8263
• Email: info@metamehealth.com
• Phone: 888-463-8263
• Email: info@metamehealth.com
• Phone: 888-463-8263
• Email: info@metamehealth.com
• Phone: 888-463-8263
• Email: info@metamehealth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860005970209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211463

FDA Product Code

• QMY: Computerized Behavioral Therapy Device For Treating Symptoms

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: 2022-05-09
• Device Publish Date: 2022-04-29