FDA UDI
In Commercial Distribution
🇺🇸 United States
reSET® Mobile App, Android
DI: 10851580008095
·
Model: 1
·
PEAR THERAPEUTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- reSET® Mobile App, Android
- Primary DI
- 10851580008095
- Version / Model
- 1
- Company Name
- PEAR THERAPEUTICS, INC.
- Labeler DUNS
- 079705123
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-15
- Public Version
- 5
- Public Version Date
- 2023-08-03
- Public Version Status
- Update
- Public Device Record Key
- 52b7de48-9aaf-4217-8f5d-19e3de465191
Device Description
reSET® Mobile Application running on Android. 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.
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 |
|---|---|---|---|---|
| 63031 | Mental health/function therapeutic software, screen-viewed | A screen-based (non-virtual-reality) software program intended to be used with an off-the-shelf computer/smart device to help improve mental health/wellbeing (e.g., control effects of mood disorders, stress) and/or a cognitive function (e.g., concentration, memory, eye movement training to improve reading) by providing a patient with on-screen interactive sessions. It may additionally be designed to assess cognition/mental health, set baselines, help manage pain, and will typically indicate development (i.e., interactive). It is not intended for kinesiology-based neuromuscular rehabilitation. It is intended to be used by the patient which may involve clinical assistance/recommendations. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10851580008095 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN160018 | 000 |