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510(k) DEN200026

EndeavorRx by Akili Interactive Labs, Inc. — Product Code QFT

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
June 15, 2020
Date Received
April 16, 2020
Clearance Type
Direct
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.

Other clearances by Akili Interactive Labs, Inc.

  • K233496 — EndeavorOTC (June 14, 2024)
  • K231337 — EndeavorRx (December 13, 2023)

Other clearances for product code QFT

  • K243729 — Prismira (June 13, 2025)
  • K233496 — EndeavorOTC (June 14, 2024)
  • K231337 — EndeavorRx (December 13, 2023)