FDA.reportPublic FDA data

PursueCare RESET-O

Primary DI
00850074433019
Brand
PursueCare RESET-O
Company
Harvest Bio LLC
Model
2.0.2
Device description
RESET-O is an iOS application intended to increase retention of opioid use disorder patients in outpatient treatment by providing cognitive behavioral therapy as an adjunct to outpatient treatment.
Published
2025-04-28
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 Substance Use 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
00850074433019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850074433019008500744330198500744330190850074433019

GMDN Terms#

Term, Definition table
TermDefinition
Mental health/function therapeutic software, screen-viewedA screen-based (non-virtual-reality) software program intended to be used with an off-the-shelf computer/smart device to help improve mental health/wellbeing (e.g., control effects of mood disorders, stress) and/or a cognitive function (e.g., concentration, memory, eye movement training to improve reading) by providing a patient with on-screen interactive sessions. It may additionally be designed to assess cognition/mental health, set baselines, help manage pain, and will typically indicate development (i.e., interactive). It is not intended for kinesiology-based neuromuscular rehabilitation. It is intended to be used by the patient which may involve clinical assistance/recommendations.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118987662
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850074433002PursueCare RESET2.0.22025-04-28
00850074433026PursueCare RESET-O2.0.22025-04-28
00850074433033PursueCare RESET2.0.22025-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850074433002PursueCare RESETHarvest 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
10851580008026reSET®PEAR THERAPEUTICS, INC.PWE2018-07-12