NHI · Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
Neurology · 21 CFR 882.5890 · Class 2
Overview
| Product Code | NHI |
|---|---|
| Device Name | Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief |
| Regulation | 21 CFR 882.5890 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K223306 | SPRINT Peripheral Nerve Stimulation (PNS) System | Spr Therapeutics, Inc. | Jan 25, 2023 | SESE |
| K221425 | Primary Relief | Dyansys, Inc. | Sep 13, 2022 | SESE |
| K220397 | ANSiStim-PP | Dyansys, Inc. | May 12, 2022 | SESE |
| K213188 | Primary Relief | Dyansys, Inc. | Jan 31, 2022 | SESE |
| K212859 | First Relief | Dyansys, Inc. | Dec 20, 2021 | SESE |
| K211801 | SPRINT PNS System | Spr Therapeutics, Inc. | Oct 13, 2021 | SESE |
| K202660 | SPRINT PNS System | Spr Therapeutics, Inc. | Jan 22, 2021 | SESE |
| K181422 | SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit | Spr Therapeutics, Inc. | Jul 31, 2018 | SESE |
| K170902 | Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit | Spr Therapeutics, LLC | Jun 26, 2017 | SESE |
| K161154 | Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs | Spr Therapeutics, LLC | Jul 23, 2016 | SESE |
| K061166 | DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM | Biowave Corporation | Aug 15, 2006 | SESE |
| K022241 | VERTIS PNT CONTROL UNIT, MODEL CU 100; VERTIS PNT SAFEGUIDE-CERVICAL, MODEL SG 102-XXX | Vertis Neuroscience, Inc. | Sep 11, 2002 | SESE |
| K011702 | VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX | Vertis Neuroscience, Inc. | Dec 21, 2001 | SESE |
Top Applicants
- Dyansys, Inc. — 4 clearances
- Spr Therapeutics, Inc. — 4 clearances
- Spr Therapeutics, LLC — 2 clearances
- Vertis Neuroscience, Inc. — 2 clearances
- Biowave Corporation — 1 clearance
