EndeavorRx™ 50002063901

GUDID 00850002639018

EndeavorRx is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. The EndeavorRx program is software-as-medical device (SaMD) that resides on the user’s mobile device and can be executed at home. EndeavorRx is engineered as a therapeutically active treatment for attention in pediatric patients affected by ADHD. EndeavorRx is built on Akili’s proprietary, patented, technology platform which is designed for the selective targeting and modulation of specific cognitive neural systems in the brain related to attention function. EndeavorRx uses Akili’s adaptive algorithms (also known as Selective Stimulus Management Engine, SSME™) to deliver the presentation of stimuli that are designed to engage targeted neural systems which play a key role in attention function. In a closed-loop system, the adaptive SSME algorithms automatically adjust the difficulty level for a personalized treatment experience that is tailored to the needs of each individual patient. EndeavorRx is delivered through a video game experience which leverages art, music, storytelling, and reward cycles to keep patients engaged. The adaptive algorithm constantly pushes patients precisely at predefined performance bounds relative to each individual, such that they are continuously encouraged to exceed their historic performance.

AKILI INTERACTIVE LABS, INC.

Cognitive therapy software Cognitive therapy software Cognitive therapy software Cognitive therapy software Cognitive therapy software Cognitive therapy software Cognitive therapy software Cognitive therapy software Cognitive therapy software Cognitive therapy software Cognitive therapy software Cognitive therapy software Cognitive therapy software Cognitive therapy software Cognitive therapy software Cognitive therapy software Cognitive therapy software Cognitive therapy software Cognitive therapy software Cognitive therapy software Cognitive therapy software Cognitive therapy software Cognitive therapy software Cognitive therapy software Cognitive therapy software Cognitive therapy software
Primary Device ID00850002639018
NIH Device Record Keyed3ec8ef-a53a-4768-bffb-71206cef7717
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndeavorRx™
Version Model NumberTreatment 1
Catalog Number50002063901
Company DUNS078413778
Company NameAKILI INTERACTIVE LABS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone617-456-0984
Emailskellogg@akiliinteractive.com
Phone617-456-0984
Emailskellogg@akiliinteractive.com
Phone617-456-0984
Emailskellogg@akiliinteractive.com
Phone617-456-0984
Emailskellogg@akiliinteractive.com
Phone617-456-0984
Emailskellogg@akiliinteractive.com
Phone617-456-0984
Emailskellogg@akiliinteractive.com
Phone617-456-0984
Emailskellogg@akiliinteractive.com
Phone617-456-0984
Emailskellogg@akiliinteractive.com
Phone617-456-0984
Emailskellogg@akiliinteractive.com
Phone617-456-0984
Emailskellogg@akiliinteractive.com
Phone617-456-0984
Emailskellogg@akiliinteractive.com
Phone617-456-0984
Emailskellogg@akiliinteractive.com
Phone617-456-0984
Emailskellogg@akiliinteractive.com
Phone617-456-0984
Emailskellogg@akiliinteractive.com
Phone1-844-254-5447
Emailinfo@akiliinteractive.com
Phone1-844-254-5447
Emailinfo@akiliinteractive.com
Phone1-844-254-5447
Emailinfo@akiliinteractive.com
Phone1-844-254-5447
Emailinfo@akiliinteractive.com
Phone1-844-254-5447
Emailinfo@akiliinteractive.com
Phone1-844-254-5447
Emailinfo@akiliinteractive.com
Phone1-844-254-5447
Emailinfo@akiliinteractive.com
Phone1-844-254-5447
Emailinfo@akiliinteractive.com
Phone1-844-254-5447
Emailinfo@akiliinteractive.com
Phone1-844-254-5447
Emailinfo@akiliinteractive.com
Phone1-844-254-5447
Emailinfo@akiliinteractive.com
Phone1-844-254-5447
Emailinfo@akiliinteractive.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]
GS100850002639018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-21
Device Publish Date2020-09-11

Trademark Results [EndeavorRx]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENDEAVORRX
ENDEAVORRX
90069243 not registered Live/Pending
Akili Interactive Labs, Inc.
2020-07-23

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