DEVICE: MamaLift Plus (00860012970308)
Device Identifier (DI) Information
MamaLift Plus
MamaLift Plus
In Commercial Distribution
Curio Digital Therapeutics Inc.
MamaLift Plus
In Commercial Distribution
Curio Digital Therapeutics Inc.
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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63031 | Mental health/function therapeutic software, screen-viewed |
A 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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SAP | Computerized Behavioral Therapy Device For Depressive Disorders. |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K223515 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
ef02a558-fedc-45cf-89d9-78726f4e70c1
February 27, 2025
1
February 19, 2025
February 27, 2025
1
February 19, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
18007629854
contact@curiodigitaltx.com
contact@curiodigitaltx.com