

# NZK · Stimulator, Low Electric Field, Tumor Treatment

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/NE-misc/NZK

## Overview

- **Product Code:** NZK
- **Device Name:** Stimulator, Low Electric Field, Tumor Treatment
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Life-sustaining:** yes

## Identification

Intended to treat tumors by application of low electic fields and indicated for treatment of recurrent glioblastoma multiforme (gbm) in patients who have received maximum standard therapy with continued disease progress, as defined by tumor growth or decline in neurological status.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P100034](https://fda.innolitics.com/submissions/NE/NE-misc/NZK/P100034.md) | NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT | Novocure, GmbH | Apr 8, 2011 | APPR |

## Top Applicants

- Novocure, GmbH — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/NE/NE-misc/NZK](https://fda.innolitics.com/submissions/NE/NE-misc/NZK)

**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
