reSET-O® Demo Version

GUDID 10851580008224

reSET-O® is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Demo Version provides demonstration access to various prescription versions of the reSET-O product and is not intended for patients.

PEAR THERAPEUTICS, INC.

Cognitive therapy software

• Primary Device ID: 10851580008224
• NIH Device Record Key: 0b7155af-7f3c-44ab-a816-3d1735aba996
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: reSET-O® Demo Version
• 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	10851580008224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173681

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-07-23
• Device Publish Date: 2019-11-25

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