Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
The Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder is a software device intended to provide therapy for ADHD or any of its individual symptoms as an adjunct to clinician-supervised treatment. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 882.5803 in the Neurology specialty. The product code is QFT. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QFT
- Device Class
- FDA class 2
- Regulation Number
- 882.5803
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243729 | Prismira | Jun 13, 2025 | Substantially Equivalent | Lumos Labs, Inc. |
| K233496 | EndeavorOTC | Jun 14, 2024 | Substantially Equivalent | Akili Interactive Labs, Inc. |
| K231337 | EndeavorRx | Dec 13, 2023 | Substantially Equivalent | Akili Interactive Labs, Inc. |
| DEN200026 | EndeavorRx | Jun 15, 2020 | Unknown | Akili Interactive Labs, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.