Definition: Stimulate Nerve Branches To Aid In The Reduction Of Symptoms Associated With Substance Use Disorders.
| Device Type ID | 3803 |
| Device Name | Percutaneous Nerve Stimulator For Opioid Withdrawal |
| Physical State | A Signal Generator Connected To Percutaneous Electrodes. |
| Technical Method | Electrical Stimulation Of Nerve Branches Using Percutaneous Electrodes. |
| Target Area | Cranial And Occipital Nerve Branches. |
| Regulation Description | Percutaneous Nerve Stimulator For Substance Use Disorders. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurostimulation Devices Psychiatry Branch (NSDP) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.5896 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PZR |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3803 |
| Device | Percutaneous Nerve Stimulator For Opioid Withdrawal |
| Product Code | PZR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Percutaneous Nerve Stimulator For Substance Use Disorders. |
| CFR Regulation Number | 882.5896 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DYANSYS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |