Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5890](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5890) → NHI — Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief

# NHI · Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief

_Neurology · 21 CFR 882.5890 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NHI

## Overview

- **Product Code:** NHI
- **Device Name:** Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
- **Regulation:** [21 CFR 882.5890](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5890)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **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](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NHI/K223306.md) | SPRINT Peripheral Nerve Stimulation (PNS) System | Spr Therapeutics, Inc. | Jan 25, 2023 | SESE |
| [K221425](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NHI/K221425.md) | Primary Relief | Dyansys, Inc. | Sep 13, 2022 | SESE |
| [K220397](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NHI/K220397.md) | ANSiStim-PP | Dyansys, Inc. | May 12, 2022 | SESE |
| [K213188](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NHI/K213188.md) | Primary Relief | Dyansys, Inc. | Jan 31, 2022 | SESE |
| [K212859](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NHI/K212859.md) | First Relief | Dyansys, Inc. | Dec 20, 2021 | SESE |
| [K211801](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NHI/K211801.md) | SPRINT PNS System | Spr Therapeutics, Inc. | Oct 13, 2021 | SESE |
| [K202660](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NHI/K202660.md) | SPRINT PNS System | Spr Therapeutics, Inc. | Jan 22, 2021 | SESE |
| [K181422](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NHI/K181422.md) | SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit | Spr Therapeutics, Inc. | Jul 31, 2018 | SESE |
| [K170902](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NHI/K170902.md) | 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](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NHI/K161154.md) | 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](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NHI/K061166.md) | DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM | Biowave Corporation | Aug 15, 2006 | SESE |
| [K022241](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NHI/K022241.md) | VERTIS PNT CONTROL UNIT, MODEL CU 100; VERTIS PNT SAFEGUIDE-CERVICAL, MODEL SG 102-XXX | Vertis Neuroscience, Inc. | Sep 11, 2002 | SESE |
| [K011702](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NHI/K011702.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NHI](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NHI)

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