Rejoyn

Primary DI
00860015066008
Brand
Rejoyn
Company
Otsuka Precision Health, Inc
Model
CT-152
Catalog number
60015006600
Device description
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.
Published
2026-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
SAPComputerized Behavioral Therapy Device For Depressive Disorders.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SAPComputerized Behavioral Therapy Device For Depressive Disorders.Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231209000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231209000RejoynOtsuka America Pharmaceutical, Inc.2024-03-30SAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857335005121PreviousGS10
00860015066008PrimaryGS10
60015006600SecondaryNDC/NHRIC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857335005121008573350051218573350051210857335005121
00860015066008008600150660088600150660080860015066008

GMDN Terms#

Term, Definition table
TermDefinition
Mental health/function therapeutic software, screen-viewedA screen-based (non-virtual-reality) software program intended to be used with an off-the-shelf computer/smart device to help improve mental health/wellbeing (e.g., control effects of mood disorders, stress) and/or a cognitive function (e.g., concentration, memory, eye movement training to improve reading, speech) by providing a patient with on-screen interactive sessions. It may additionally be designed to assess cognition/mental health, set baselines, help manage pain, and will typically track development (i.e., interactive). It is not intended for kinesiology-based neuromuscular rehabilitation. It is intended to be used by the patient and may involve clinical assistance/recommendations.

Contacts#

Phone, Email table
PhoneEmail
833-973-5696connect@otsuka-oph.com

Regulatory Flags#

DUNS number
080200661
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
60015006600RejoynCT-152600150066002026-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
60015006600RejoynOtsuka Precision Health, IncSAP2026-01-05
00860012970308MamaLift PlusCurio Digital Therapeutics Inc.SAP2025-02-19
00857335005121RejoynOtsuka Pharmaceutical Development & Commercialization, Inc.SAP2024-07-02