510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223515Substantially Equivalent

MamaLift Plus

Curio Digital Therapeutics, Princeton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223515 is the FDA 510(k) clearance record for MamaLift Plus, a class II device, cleared for Curio Digital Therapeutics, Inc. on under FDA product code SAP (Computerized Behavioral Therapy Device For Depressive Disorders.). FDA's definition for product code SAP reads: "The device is intended to provide computerized behavioral therapy to treat depressive disorders". FDA records list one 510(k) clearance for Curio Digital Therapeutics, Inc. As of , FDA records show no recalls naming K223515.

Clearance record

Decision date
Received
(517 days to decision)
Product code
SAP Computerized Behavioral Therapy Device For Depressive Disorders.
Regulation
21 CFR 882.5801
Device class
Class II
Review panel
Neurology
Applicant
Curio Digital Therapeutics, Inc. 100 Overlook Ctr Floor 2, Princeton NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SAP

Trailing 12 months
1 clearance under product code SAP in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SAP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260