reSET-O™ N/A

GUDID 10851580008057

reSET-O Mobile Application runs on iOS. reSET-O is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only Mobile Medical Application. Limitations of Use: reSET-O has not been shown to decrease illicit drug use or improve abstinence in patients with OUD.

PEAR THERAPEUTICS, INC.

Cognitive therapy software

• Primary Device ID: 10851580008057
• NIH Device Record Key: 3afad97c-0fb7-49b6-b0f8-94d2d36c81fa
• Commercial Distribution Discontinuation: 2019-12-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: reSET-O™
• Version Model Number: 1.1
• 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	10851580008057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173681

FDA Product Code

• PWE: Cognitive 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: 2019-12-18
• Device Publish Date: 2018-12-26

On-Brand Devices [reSET-O™]

• 10851580008064: reSET-O Mobile Application runs on Android. reSET-O is intended to increase retention of patient
• 10851580008057: reSET-O Mobile Application runs on iOS. reSET-O is intended to increase retention of patients w