Rejoyn 57335000512

GUDID 00857335005121

Rejoyn (also known as CT-152) is a digital therapeutic smartphone application (app) for the treatment of Major Depressive Disorder (MDD) symptoms. Rejoyn is a prescription smartphone app-based digital therapeutic administered to a user via the user’s smartphone device (running Apple iPhone operating system [iOS®] or Android™ operating system [OS]), which delivers a proprietary interactive cognitive emotional and behavioral therapeutic intervention. The core components of Rejoyn are the Emotional Faces Memory Task (EFMT) exercises, brief cognitive behavioral therapy (CBT)-based lessons to learn and apply key therapeutic skills, and short message service (SMS) text messaging to reinforce CBT-based lesson content and to encourage engagement with the app. It is intended for the treatment of MDD symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older. It is intended to reduce MDD symptoms. Rejoyn is designed for use as an adjunct to clinician-managed outpatient care over a period of 6 weeks for the treatment of MDD symptoms, followed by a 4-week extension period where CBT-based lesson content will be accessible but no new therapeutic content or EFMT exercises will be available. Rejoyn is not intended to be used as a stand-alone therapy or as a substitution for the patient’s clinician prescribed medications.

Otsuka Pharmaceutical Development & Commercialization, Inc.

Mental health/function therapeutic software, screen-viewed

• Primary Device ID: 00857335005121
• NIH Device Record Key: 74ae6dfb-d044-4107-9023-953a99a176b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rejoyn
• Version Model Number: CT-152
• Catalog Number: 57335000512
• Company DUNS: 126812382
• Company Name: Otsuka Pharmaceutical Development & Commercialization, 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: 833-973-5696
• Email: connect@otsuka-oph.com
• Phone: 833-973-5696
• Email: connect@otsuka-oph.com
• Phone: 833-973-5696
• Email: connect@otsuka-oph.com
• Phone: 833-973-5696
• Email: connect@otsuka-oph.com
• Phone: 833-973-5696
• Email: connect@otsuka-oph.com
• Phone: 833-973-5696
• Email: connect@otsuka-oph.com
• Phone: 833-973-5696
• Email: connect@otsuka-oph.com
• Phone: 833-973-5696
• Email: connect@otsuka-oph.com
• Phone: 833-973-5696
• Email: connect@otsuka-oph.com
• Phone: 833-973-5696
• Email: connect@otsuka-oph.com
• Phone: 833-973-5696
• Email: connect@otsuka-oph.com
• Phone: 833-973-5696
• Email: connect@otsuka-oph.com
• Phone: 833-973-5696
• Email: connect@otsuka-oph.com
• Phone: 833-973-5696
• Email: connect@otsuka-oph.com
• Phone: 833-973-5696
• Email: connect@otsuka-oph.com
• Phone: 833-973-5696
• Email: connect@otsuka-oph.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857335005121 [Primary]
NDC/NHRIC	57335-0005-12 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231209

FDA Product Code

• SAP: Computerized Behavioral Therapy Device For Depressive Disorders.

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: 2024-07-10
• Device Publish Date: 2024-07-02