Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device digital therapeutic software 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.
  GRANTED 1
AKILI INTERACTIVE LABS, INC.
  SUBSTANTIALLY EQUIVALENT 2

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

-
-