| Device Type ID | 3734 |
| Device Name | Stimulator, Cranial Electrotherapy |
| Regulation Description | Cranial Electrotherapy Stimulator. |
| 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 | 882.5800 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | JXK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3734 |
| Device | Stimulator, Cranial Electrotherapy |
| Product Code | JXK |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Cranial Electrotherapy Stimulator. |
| CFR Regulation Number | 882.5800 [🔎] |