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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device digital therapeutic software for attention deficit hyperactivity disorder
Regulation Description Digital therapy device for Attention Deficit Hyperactivity Disorder.
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.
Product CodeQFT
Regulation Number 882.5803
Device Class 2


Premarket Reviews
ManufacturerDecision
AKILI INTERACTIVE LABS, INC.
  SUBSTANTIALLY EQUIVALENT 2
LUMOS LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Nausea 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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