Definition: Used To Apply An Electrical Current To A Patient's Cranium Through Electrodes Placed On The Skin.
| Device Type ID | 3781 |
| Device Name | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
| Physical State | Electrical Stimulation Unit With Leads And Cutaneous Electrodes. |
| Technical Method | Applies An Electrical Current Through Electrodes On Patient's Skin. |
| Target Area | Afferent Cranial Nerves. |
| Regulation Description | Transcutaneous Electrical Nerve Stimulator To Treat Headache. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurostimulation Devices Neurology Branch (NSDN) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.5891 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PCC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3781 |
| Device | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
| Product Code | PCC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Transcutaneous Electrical Nerve Stimulator To Treat Headache. |
| CFR Regulation Number | 882.5891 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CEFALY TECHNOLOGY | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
STX-MED SPRL | ||
GRANTED | 1 | |