Definition: A Thermal System For Insomnia Is A Prescription Device For Use In Patients With Insomnia That Is Used To Apply A Specified Temperature To The Skin Surface.
| Device Type ID | 3788 |
| Device Name | Thermal System For Insomnia |
| Physical State | Applies A Specified Temperature To The Skin Surface In Patients With Insomnia. |
| Technical Method | Applies A Specified Temperature To The Skin Surface In Patients With Insomnia. |
| Target Area | Skin Surface. |
| Regulation Description | Thermal System For Insomnia. |
| 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 | 882.5700 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PLU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3788 |
| Device | Thermal System For Insomnia |
| Product Code | PLU |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Thermal System For Insomnia. |
| CFR Regulation Number | 882.5700 [🔎] |