Chrysalis Intelligence · Product Codes · QFT

QFT · Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder

Obstetrics/Gynecology · 4 clearances · 2 unique sponsors

Device class
Class II
Regulation 882.5803
Total clearances
4
2020-06-15 → 2025-06-13
Last 12 months
0
Unique sponsors
2
Definition

What is Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder

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.
Medical specialty
Obstetrics/Gynecology
Review panel
NE
Regulation number
882.5803
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Akili Interactive Labs, Inc. 3 0 2024-06-14
Lumos Labs, Inc. 1 0 2025-06-13
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
90834 CPT — Medium Psychotherapy 45 minutes; may apply if digital therapeutic is supervised by clinician
92602 CPT — Medium Computer-assisted psychological/psychiatric testing; automated clinical interview and data gathering
0A9T HCPCS — Low Digital behavioral health device; nascent HCPCS category for digital therapeutics
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-06-13 K243729 Lumos Labs, Inc. Prismira
2024-06-14 K233496 Akili Interactive Labs, Inc. EndeavorOTC
2023-12-13 K231337 Akili Interactive Labs, Inc. EndeavorRx
2020-06-15 DEN200026 Akili Interactive Labs, Inc. EndeavorRx