Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart G](/submissions/EN/subpart-g%E2%80%94) → [21 CFR 874.6000](/submissions/EN/subpart-g%E2%80%94/874.6000) → QNU — Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion

# QNU · Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion

_Ear, Nose, Throat · 21 CFR 874.6000 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-g%E2%80%94/QNU

## Overview

- **Product Code:** QNU
- **Device Name:** Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion
- **Regulation:** [21 CFR 874.6000](/submissions/EN/subpart-g%E2%80%94/874.6000)
- **Device Class:** 2
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)

## Identification

A transcutaneous electrical nerve stimulator for the relief of congestion is a device that electrically stimulates the skin overlying the paranasal sinuses to relieve congestion.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN200006](https://fda.innolitics.com/submissions/EN/subpart-g%E2%80%94/QNU/DEN200006.md) | ClearUP Sinus Relief | Tivic Health Systems, Inc. | Mar 5, 2021 | DENG |

## Top Applicants

- Tivic Health Systems, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/EN/subpart-g%E2%80%94/QNU](https://fda.innolitics.com/submissions/EN/subpart-g%E2%80%94/QNU)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
