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MamaLift Plus

FDA 510(k)

Class II (US FDA 510(k))

510(k) K223515

by Curio Digital Therapeutics, Inc.

Identifiers

510(k) Number
K223515 FDA 510(k)
FDA Product Code
SAP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5801 FDA 510(k)
Regulation Number
882.5801 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

MamaLift Plus is a Computerized Behavioral Therapy Device for Depressive Disorders, classified as a Class II medical device under FDA regulation 882.5801. It is designed as a digital therapeutic to address symptoms of depressive disorders, specifically targeting postpartum depression (PPD). The device delivers structured, evidence-based behavioral therapy through an app-based platform, providing guided interventions and support for users.

MamaLift Plus is supplied as a software application, intended for use in home or outpatient settings. It is a single-use digital program, requiring no physical sterilization or reprocessing. The device operates without MRI compatibility concerns and is not subject to size or storage restrictions beyond standard electronic device requirements. Its FDA clearance (K223515) under the 510(k) pathway confirms regulatory compliance for symptomatic treatment of depressive disorders in the specified population.

Frequently asked questions

What is MamaLift Plus used for?

MamaLift Plus is a digital therapeutic designed to address symptoms of depressive disorders, specifically targeting postpartum depression (PPD). It provides structured, evidence-based behavioral therapy through an app-based platform, offering guided interventions and support tailored for users experiencing PPD.

How is MamaLift Plus supplied and used?

MamaLift Plus is supplied exclusively as a software application, intended for use on personal electronic devices in home or outpatient settings. It does not require physical hardware or reprocessing, making it a convenient, single-use digital program for users.

Is MamaLift Plus sterile or reusable?

Since MamaLift Plus is a digital therapeutic delivered via software, it does not require sterilization or reprocessing. Each user accesses a single-use digital program, eliminating concerns about contamination or reuse.

Does MamaLift Plus have any size or storage restrictions?

No, MamaLift Plus does not impose size or storage restrictions beyond standard electronic device requirements. It operates on compatible smartphones or tablets, requiring only internet connectivity and sufficient storage space for the app installation.

What regulatory approval does MamaLift Plus hold?

MamaLift Plus holds FDA clearance under the 510(k) pathway (K223515), confirming its regulatory compliance for symptomatic treatment of depressive disorders in the postpartum population. The device is classified as a Class II medical device under FDA regulation 882.5801.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Introducing MamaLift Plus | Curio Digital Therapeutics, MamaLift Plus | new mom mental health support, Curio Digital Therapeutics Inc. Announces the U.S. Food and Drug ..., Curio Digital Therapeutics | women's health

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Curio Digital Therapeutics, Inc.

Sources (1)

  • FDA 510(k) K223515 24 fields · synced Oct 1, 2026