FDA UDI
Not in Commercial Distribution
🇺🇸 United States
reSET-O™
DI: 10851580008064
·
Model: 1.1
·
PEAR THERAPEUTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- reSET-O™
- Primary DI
- 10851580008064
- Version / Model
- 1.1
- Catalog Number
- N/A
- Company Name
- PEAR THERAPEUTICS, INC.
- Labeler DUNS
- 079705123
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-26
- Public Version
- 6
- Public Version Date
- 2023-08-03
- Public Version Status
- Update
- Public Device Record Key
- 902cf08a-af6e-4fb2-ab22-a30b9097a495
- Distribution End Date
- 2019-12-03
Device Description
reSET-O Mobile Application runs on Android. 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.
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 | Cognitive 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 | 10851580008064 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173681 | 000 |