FDA.reportPublic FDA data

510(k) K254038

Device
Motivista (CT-155)
Applicant
Click Therapeutics, Inc.
510(k) number
K254038
Product code
SAP
Decision
Substantially Equivalent (SESE)
Decision date
2026-07-30
Date received
2025-12-16
Regulation
882.5801
Classification name
Computerized Behavioral Therapy Device For Depressive Disorders.
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Austin Speier
Address
80 White St., 3rd Floor New York NY US 10013 10013

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code SAP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K223515MamaLift PlusCurio Digital Therapeutics, Inc.2024-04-22
K231209RejoynOtsuka America Pharmaceutical, Inc.2024-03-30