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510(k) K231337

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2023
Date Received
May 8, 2023
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.

Other clearances by Akili Interactive Labs, Inc.

  • K233496 — EndeavorOTC (June 14, 2024)
  • DEN200026 — EndeavorRx (June 15, 2020)

Other clearances for product code QFT

  • K243729 — Prismira (June 13, 2025)
  • K233496 — EndeavorOTC (June 14, 2024)
  • DEN200026 — EndeavorRx (June 15, 2020)