510(k) DEN240064
DEN240064 is an FDA 510(k) premarket notification submitted by Click Therapeutics, Inc. for the device "CT-132". The FDA issued a decision of De Novo Granted on Apr 11, 2025. The device falls under product code SEE (Computerized Behavioral Therapy Device For Migraine), a Class II device regulated under 21 CFR 882.5806. Click Therapeutics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Apr 11, 2025
- Date Received
- Nov 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.