FDA.reportPublic FDA data

reSET-O®

Primary DI
10196439000029
Brand
reSET-O®
Company
PEAR THERAPEUTICS, INC.
Model
1
Catalog number
N/A
Device description
reSET-O is intended to increase retention of patients with Opioid Use Disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic. This configuration of reSET-O is intended to provide virtual incentives as well as monetary incentives to the patients based on the Contingency management system.
Published
2022-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PWEComputerized 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
K173681000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173681000reSET-OPear Therapeutics, Inc.2018-12-10PWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10196439000029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019643900002910196439000029

GMDN Terms#

Term, Definition table
TermDefinition
Psychological assessment softwareA software program intended to be used by patients and medical professionals to evaluate and determine the psychological profile of the patient; it may be used to monitor the effectiveness and progress of psychotherapy given to patients affected by mental health conditions and associated issues (e.g., psychiatric disorder, child behavioural difficulties, alcohol/drug addiction, eating disorders, depression). It typically uses psychological tests/questionnaires and patient demographics (e.g., smartphone digital phenotype) to establish a mental wellbeing score, and may also provide self-help resources to promote patient awareness and recovery (e.g., automated online chat).

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
10851580008026reSET®1.5N/A2018-07-12
10851580008033reSET®1.5N/A2018-07-12
10851580008057reSET-O™1.1N/A2018-12-26
10851580008064reSET-O™1.1N/A2018-12-26
10851580008071reSET®12019-07-15

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
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
10851580008026reSET®PEAR THERAPEUTICS, INC.PWE2018-07-12