# CoolTone

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/cooltone-ngx-k192940>
- Manufacturer: [Zimmer MedizinSysteme GmbH](https://devicerts.com/manufacturers/zimmer-medizinsystems-gmbh) (Germany)
- Device class: Class II (US FDA)
- FDA product code: NGX

## Overview

*AI-generated summary, 2026-10-01. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The CoolTone System is a neuromuscular electrical stimulation (NMES) device designed for adjunctive therapy in physical medicine. It delivers targeted electrical impulses to facilitate muscle activation, aiding in rehabilitation and muscle training protocols under medical supervision. The device is classified as substantially equivalent to the predicate BTL-899MS, adhering to regulatory standards for physical medicine applications. Its primary function is to assist in muscle stimulation and recovery processes, supporting therapeutic interventions for patients.

The CoolTone System is supplied as a reusable medical device and is intended for use in clinical or therapeutic settings. It operates under sterile conditions when in direct contact with the patient, though the device itself may not be single-use. The system is not labeled as MRI-safe or unsafe, and no specific storage requirements beyond standard medical equipment protocols are noted. Authorized for use in the United States under FDA 510(k) clearance (K253408), it follows regulatory pathways established for neuromuscular stimulation devices in physical medicine. No additional certifications or approvals beyond the stated FDA clearance are referenced.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K192940 · decision 2019-11-15 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K192940 [FDA 510(k)]
- FDA product code: NGX [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 890.5850 [FDA 510(k)]
- Advisory committee: Physical Medicine [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: CoolTone, Zimmer MedizinSysteme GmbH. deviCERTS medical device catalogue. https://devicerts.com/devices/cooltone-ngx-k192940 (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/cooltone-ngx-k192940.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/cooltone-ngx-k192940
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.