Device Atlas

Motivista (CT-155)

Q: When was Motivista (CT-155) cleared by the FDA?

Motivista (CT-155) (K254038) received a 510(k) decision of Substantially Equivalent on July 30, 2026, 226 days after the submission was received.

Q: What is the product code of K254038?

The FDA product code is SAP – Computerized Behavioral Therapy Device For Depressive Disorders., a Class II (moderate risk) device regulated under 21 CFR 882.5801.

FDA 510(k) K254038 · Click Therapeutics, Inc.

Substantially Equivalent

510(k) numberK254038

Submission

Device name: Motivista (CT-155)
Applicant: Click Therapeutics, Inc.
New York, NY, US
Received: December 16, 2025
Decision date: July 30, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: SAP – Computerized Behavioral Therapy Device For Depressive Disorders.
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5801
Specialty: Neurology

The device is intended to provide computerized behavioral therapy to treat depressive disorders.

Other 510(k)s with product code SAP

510(k)	Device	Applicant	Decision
K223515	MamaLift PlusSAP · Traditional	Curio Digital Therapeutics, Inc.	04/22/2024SE
K231209	RejoynSAP · Traditional	Otsuka America Pharmaceutical, Inc.	03/30/2024SE

Questions and answers

When was Motivista (CT-155) cleared by the FDA?

Motivista (CT-155) (K254038) received a 510(k) decision of Substantially Equivalent on July 30, 2026, 226 days after the submission was received.

What is the product code of K254038?

The FDA product code is SAP – Computerized Behavioral Therapy Device For Depressive Disorders., a Class II (moderate risk) device regulated under 21 CFR 882.5801.