510(k) K243729
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 2025
- Date Received
- December 3, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
- Device Class
- Class II
- Regulation Number
- 882.5803
- Review Panel
- NE
- Submission Type
A digital therapy device for Attention Deficit Hyperactivity Disorder (ADHD) is a software intended to provide therapy for ADHD or any of its individual symptoms as an adjunct to clinician supervised treatment.