reSET®

Primary DI
10851580008026
Brand
reSET®
Company
PEAR THERAPEUTICS, INC.
Model
1.5
Catalog number
N/A
Device description
reSET Mobile Application runs on iOS. reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12 week (90 days) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to -- increase abstinence from a patient’s substances of abuse during treatment, and- increase retention in the outpatient treatment program.
Published
2018-07-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PWECognitive Behavioral Therapy Device For Psychiatric Disorders

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWEComputerized Behavioral Therapy Device For Substance Use DisordersNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN160018000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN160018000reSetPear Therapeutics, Inc.2017-09-14PWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851580008026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085158000802610851580008026

GMDN Terms#

Term, Definition table
TermDefinition
Cognitive therapy softwareA software program intended to be used with an off-the-shelf computer/tablet/smartphone to help improve a cognitive function (e.g., attention/concentration, memory, eye movement training to improve reading ability) by providing a patient with on-screen interactive sessions (e.g., text for audible reading); it is not intended to detect/display a patient’s physical movements/actions. It may additionally be designed to screen for cognitive disorders, set baselines, and will typically show development (i.e., interactive). It is intended to be used by parents, educators, specialists and medical professionals at home, school or in a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079705123
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10851580008255Somryst™12020-09-09
10851580008019reSET®1.4.62017-12-11
10851580008040reSET®1.42018-07-12
10851580008132reSET® Introductory Access Limited Version12019-08-25
10851580008149reSET® Introductory Access Limited Version (Mobile App, iOS)12019-08-25
10851580008156reSET® Introductory Access Limited Version (Mobile App, Android)12019-08-25
10851580008163reSET-O® Introductory Access Limited Version12019-08-25
10851580008170reSET-O® Introductory Access Limited Version (Mobile App, iOS)12019-08-25
10851580008187reSET-O® Introductory Access Limited Version (Mobile App, Android)12019-08-25
10851580008194reSET® Demo Version12019-11-25
10851580008200reSET® Demo Version (Mobile App, iOS)12019-11-25
10851580008217reSET® Demo Version (Mobile App, Android)12019-11-25
10851580008224reSET-O® Demo Version12019-11-25
10851580008231reSET-O® Demo Version (Mobile App, iOS)12019-11-25
10851580008248reSET-O® Demo Version (Mobile App, Android)12019-11-25
10851580008033reSET®1.5N/A2018-07-12
10851580008057reSET-O™1.1N/A2018-12-26
10851580008064reSET-O™1.1N/A2018-12-26
10851580008071reSET®12019-07-15
10851580008088reSET® Mobile App, iOS12019-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850074433002PursueCare RESETHarvest Bio LLCPWE2025-04-28
00850074433019PursueCare RESET-OHarvest Bio LLCPWE2025-04-28
00850074433026PursueCare RESET-OHarvest Bio LLCPWE2025-04-28
00850074433033PursueCare RESETHarvest Bio LLCPWE2025-04-28
10196439000005reSET®PEAR THERAPEUTICS, INC.PWE2022-06-08
10196439000012reSET® Non-Monetary CMPEAR THERAPEUTICS, INC.PWE2022-06-08
10196439000029reSET-O®PEAR THERAPEUTICS, INC.PWE2022-06-08
10196439000036reSET-O® Non-Monetary CMPEAR THERAPEUTICS, INC.PWE2022-06-08
10851580008255Somryst™PEAR THERAPEUTICS, INC.PWE2020-09-09
10851580008194reSET® Demo VersionPEAR THERAPEUTICS, INC.PWE2019-11-25
10851580008200reSET® Demo Version (Mobile App, iOS)PEAR THERAPEUTICS, INC.PWE2019-11-25
10851580008217reSET® Demo Version (Mobile App, Android)PEAR THERAPEUTICS, INC.PWE2019-11-25
10851580008224reSET-O® Demo VersionPEAR THERAPEUTICS, INC.PWE2019-11-25
10851580008231reSET-O® Demo Version (Mobile App, iOS)PEAR THERAPEUTICS, INC.PWE2019-11-25
10851580008248reSET-O® Demo Version (Mobile App, Android)PEAR THERAPEUTICS, INC.PWE2019-11-25
10851580008132reSET® Introductory Access Limited VersionPEAR THERAPEUTICS, INC.PWE2019-08-25
10851580008149reSET® Introductory Access Limited Version (Mobile App, iOS)PEAR THERAPEUTICS, INC.PWE2019-08-25
10851580008156reSET® Introductory Access Limited Version (Mobile App, Android)PEAR THERAPEUTICS, INC.PWE2019-08-25
10851580008163reSET-O® Introductory Access Limited VersionPEAR THERAPEUTICS, INC.PWE2019-08-25
10851580008170reSET-O® Introductory Access Limited Version (Mobile App, iOS)PEAR THERAPEUTICS, INC.PWE2019-08-25
10851580008187reSET-O® Introductory Access Limited Version (Mobile App, Android)PEAR THERAPEUTICS, INC.PWE2019-08-25
10851580008071reSET®PEAR THERAPEUTICS, INC.PWE2019-07-15
10851580008088reSET® Mobile App, iOSPEAR THERAPEUTICS, INC.PWE2019-07-15
10851580008095reSET® Mobile App, AndroidPEAR THERAPEUTICS, INC.PWE2019-07-15
10851580008101reSET-O®PEAR THERAPEUTICS, INC.PWE2019-07-15
10851580008118reSET-O® Mobile App, iOSPEAR THERAPEUTICS, INC.PWE2019-07-15
10851580008125reSET-O® Mobile App, AndroidPEAR THERAPEUTICS, INC.PWE2019-07-15
10851580008057reSET-O™PEAR THERAPEUTICS, INC.PWE2018-12-26
10851580008064reSET-O™PEAR THERAPEUTICS, INC.PWE2018-12-26
10851580008040reSET®PEAR THERAPEUTICS, INC.PWE2018-07-12