MamaLift Plus— 510(k) K223515

Substantially Equivalent

Curio Digital Therapeutics, Inc.

FDA 510(k) clearance K223515 for MamaLift Plus, Substantially Equivalent on 2024-04-22. Applicant: Curio Digital Therapeutics, Inc.. Device class: 2.

Clearance details

Applicant
Curio Digital Therapeutics, Inc.
Product code
Code SAP
Device class
Class 2
Regulation
21 CFR 882.5801
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Princeton, NJ, US
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Recent devices under product code SAP

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Adverse events under product code SAP

product code SAP
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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