Definition: Percutaneous Electrical Nerve Stimulator (pens) Is A Device Used For The Treatment Of Pain. Unlike The Classified Transcutaneous Electrical Nerve Stimulator That Apply An Electrical Current To Electrodes On A Patient's Skin To Deliver Stimulation, A
| Device Type ID | 3748 |
| Device Name | Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief |
| Regulation Description | Transcutaneous Electrical Nerve Stimulator For Pain Relief. |
| 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 | 882.5890 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NHI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3748 |
| Device | Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief |
| Product Code | NHI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Transcutaneous Electrical Nerve Stimulator For Pain Relief. |
| CFR Regulation Number | 882.5890 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SPR THERAPEUTICS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |