NHI — Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief Class II
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 |