reSET-O®

Basic Information

• Brand Name: reSET-O®
• Primary DI: 10196439000029
• Version / Model: 1
• Catalog Number: N/A
• Company Name: PEAR THERAPEUTICS, INC.
• Labeler DUNS: 079705123
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-08
• Public Version: 2
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: 711ad631-d3b6-452a-b9e7-315b0f16eeb2

Device Description

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 digital therapeutic. This configuration of reSET-O is intended to provide virtual incentives as well as monetary incentives to the patients based on the Contingency management system.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PWE	Computerized Behavioral Therapy Device For Psychiatric Disorders	Neurology	882.5801	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58290	Psychological assessment software	A screen-based (non-virtual-reality) software program intended to be used by patients and medical professionals to evaluate and determine the psychological profile of the patient; it may in addition be used to monitor the effectiveness and progress of psychotherapy, however it is not primarily intended to provide interactive therapy. It typically uses psychological tests/questionnaires and patient demographics (e.g., smartphone digital phenotype) to establish a mental wellbeing score, and may also provide resources to promote patient awareness and recovery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10196439000029	GS1

Premarket Submissions

Submission Number	Supplement Number
K173681	000