reSET® Non-Monetary CM N/A

GUDID 10196439000012

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) prescriptiononly 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 This configuration of reSET is intended to provide virtual incentives to patients based on the Contingency management system.

PEAR THERAPEUTICS, INC.

Psychological assessment software

• Primary Device ID: 10196439000012
• NIH Device Record Key: d29da6cb-27a8-4a6c-a97d-755482644692
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: reSET® Non-Monetary CM
• Version Model Number: 1
• Catalog Number: N/A
• Company DUNS: 079705123
• Company Name: PEAR THERAPEUTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10196439000012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN160018

FDA Product Code

• PWE: Computerized Behavioral Therapy Device For Psychiatric Disorders

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-16
• Device Publish Date: 2022-06-08

Devices Manufactured by PEAR THERAPEUTICS, INC.

• 10196439000005 - reSET®: 2022-06-16 reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 yea
• 10196439000012 - reSET® Non-Monetary CM: 2022-06-16reSET 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) prescriptiononly 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 This configuration of reSET is intended to provide virtual incentives to patients based on the Contingency management system.
• 10196439000012 - reSET® Non-Monetary CM: 2022-06-16 reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 yea
• 10196439000029 - reSET-O®: 2022-06-16 reSET-O is intended to increase retention of patients with Opioid Use Disorder (OUD) in outpatient treatment by providing cognit
• 10196439000036 - reSET-O® Non-Monetary CM: 2022-06-16 reSET-O is intended to increase retention of patients with Opioid Use Disorder (OUD) in outpatient treatment by providing cognit
• 10851580008255 - Somryst™: 2020-09-17 Somryst is a prescription-only digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Ther
• 10851580008019 - reSET®: 2020-07-23 "reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 ye
• 10851580008040 - reSET®: 2020-07-23 reSET Web Dashboard is available using an internet browser. reSET is intended to provide cognitive behavioral therapy, as an adj
• 10851580008132 - reSET® Introductory Access Limited Version: 2020-07-23 reSET® is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance