DEN240064 is an FDA 510(k) submission for the CT-132. This device is classified as a Computerized Behavioral Therapy Device For Migraine (Class II - Special Controls, product code SEE).
Submitted by Click Therapeutics, Inc. (New York, US). The FDA issued a Not Cleared (DENG) decision on April 11, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5806. 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..
| 510(k) Number | DEN240064 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | November 12, 2024 |
| Decision Date | April 11, 2025 |
| Days to Decision | 150 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | SEE - Computerized Behavioral Therapy Device For Migraine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5806 |
| Definition | 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. |