Definition: The Device Is Intended To Provide Cognitive Behavioral Therapy To Treat Substance Use Disorder.
| Device Type ID | 3802 |
| Device Name | Computerized Behavioral Therapy Device For Psychiatric Disorders |
| Physical State | The Device Is A Software-based Mobile App Downloaded Onto A Smartphone. |
| Technical Method | The Device Is A Software-based Mobile App That Provides A Computerized Version Of Behavioral Therapy To The Patient. |
| Target Area | The Device Is Intended To Provided Psychiatric Treatment. |
| Regulation Description | Computerized Behavioral Therapy Device For Psychiatric Disorders. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.5801 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PWE |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3802 |
| Device | Computerized Behavioral Therapy Device For Psychiatric Disorders |
| Product Code | PWE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Computerized Behavioral Therapy Device For Psychiatric Disorders. |
| CFR Regulation Number | 882.5801 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PEAR THERAPEUTICS, INC. | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |