FDA.reportPublic FDA data

PursueCare RESET

Primary DI
00850074433033
Brand
PursueCare RESET
Company
Harvest Bio LLC
Model
2.0.2
Device description
RESET Mobile Application runs on Andriod and is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older.
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
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
00850074433033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850074433033008500744330338500744330330850074433033

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
00850074433019PursueCare RESET-O2.0.22025-04-28
00850074433026PursueCare RESET-O2.0.22025-04-28

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
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