NHI — Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief Class II
FDA product code NHI covers "Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief", a Class II medical device regulated under 21 CFR 882.5890. Submissions are reviewed by the Neurology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NHI
- Device Class
- Class II
- Regulation Number
- 882.5890
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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,
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K223306 | spr therapeutics | SPRINT Peripheral Nerve Stimulation (PNS) System | January 25, 2023 |
| K221425 | dyansys | Primary Relief | September 13, 2022 |
| K220397 | dyansys | ANSiStim-PP | May 12, 2022 |
| K213188 | dyansys | Primary Relief | January 31, 2022 |
| K212859 | dyansys | First Relief | December 20, 2021 |
| K211801 | spr therapeutics | SPRINT PNS System | October 13, 2021 |
| K202660 | spr therapeutics | SPRINT PNS System | January 22, 2021 |
| K181422 | spr therapeutics | SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Sti | July 31, 2018 |
| K170902 | spr therapeutics | Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure | June 26, 2017 |
| K161154 | spr therapeutics | Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and A | July 23, 2016 |
| K061166 | biowave corporation | DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM | August 15, 2006 |
| K022241 | vertis neuroscience | VERTIS PNT CONTROL UNIT, MODEL CU 100; VERTIS PNT SAFEGUIDE-CERVICAL, MODEL SG 1 | September 11, 2002 |
| K011702 | vertis neuroscience | VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX | December 21, 2001 |