510(k) DEN240064

CT-132 by Click Therapeutics, Inc. — Product Code SEE

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: April 11, 2025
Date Received: November 12, 2024
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Computerized Behavioral Therapy Device For Migraine
Device Class: Class II
Regulation Number: 882.5806
Review Panel: NE
Submission Type

A computerized behavioral therapy device for headache is a prescription device intended to provide a computerized version of behavioral therapy for the treatment of headache.