Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
NHI is the FDA product code for Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief, a class II device type, regulated under 21 CFR 882.5890. FDA's definition for this code reads: "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 pens uses electrodes that are placed percutaneously to deliver...". As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- NHI
- Device name
- Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
- FDA 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 pens uses electrodes that are placed percutaneously to deliver stimulation,
- Regulation
- 21 CFR 882.5890
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 13
- Ingested recalls
- 0
Clearances, product code NHI
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2002 | 1 |
| 2006 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2021 | 3 |
| 2022 | 3 |
| 2023 | 1 |
Applicants with the most clearances
Product code NHI| Applicant | Clearances |
|---|---|
| SPR Therapeutics, Inc | 6 |
| Dyansys, Inc. | 4 |
| Vertis Neuroscience, Inc. | 2 |
| Biowave Corporation | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
