MamaLift Plus

Primary DI
00860012970308
Brand
MamaLift Plus
Company
Curio Digital Therapeutics Inc.
Model
MamaLift Plus
Device description
MamaLift Plus is a digital therapy designed to treat symptoms of postpartum depression by delivering evidence-based therapeutic components of Cognitive Behavioral Therapy via software on a mobile application, such as a smartphone or tablet.
Published
2025-02-19
Public version status
Update
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
K223515000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223515000MamaLift PlusCurio Digital Therapeutics, Inc.2024-04-22SAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012970308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012970308008600129703088600129703080860012970308

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) 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 indicate development (i.e., interactive). It is not intended for kinesiology-based neuromuscular rehabilitation. It is intended to be used by the patient which may involve clinical assistance/recommendations.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18007629854contact@curiodigitaltx.com

Regulatory Flags#

DUNS number
117612997
Device count
1
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015066008RejoynOtsuka Precision Health, IncSAP2026-01-05
60015006600RejoynOtsuka Precision Health, IncSAP2026-01-05
00857335005121RejoynOtsuka Pharmaceutical Development & Commercialization, Inc.SAP2024-07-02