reSET® Mobile App, iOS

GUDID 10851580008088

reSET® Mobile Application running 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.

PEAR THERAPEUTICS, INC.

Cognitive therapy software

• Primary Device ID: 10851580008088
• NIH Device Record Key: 6c90b961-5b2e-41e3-86ca-31326bc51dcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: reSET® Mobile App, iOS
• Version Model Number: 1
• 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	10851580008088 [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: 2019-07-23
• Device Publish Date: 2019-07-15

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: 2022-06-16 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