Romet
Experience the power of communication with the Romet R120 Electronic Larynx, a cutting-edge device designed to empower laryngectomees and provide a seamless transition to vocal expression.…
Experience the power of communication with the Romet R120 Electronic Larynx, a cutting-edge device designed to empower laryngectomees and provide a seamless transition to vocal expression. With its exceptional features and reliable performance, this device is a must-have for anyone seeking a dependable electronic larynx unit. Effortless Control: The Romet R120 is equipped with a convenient on/off switch, providing easy functionality without overwhelming you with unnecessary volume or pitch controls. With simplicity in mind, this device allows you to focus on what matters most → expressing yourself and connecting with others. Economical and Versatile: The Romet R120 is an economical choice that can be used as your primary electronic larynx or as a reliable backup device. We understand the importance of having a dependable solution at hand, and this device is designed to seamlessly integrate into your daily life. Uninterrupted Communication: We care about your uninterrupted communication experience. That’s why the Romet R120 includes two rechargeable 9V lithium batteries, ensuring that you always have a reliable power source available. Say goodbye to battery anxiety and hello to consistent communication. Empowering Laryngectomees: Developed with the needs of laryngectomees in mind, the Romet R120 caters to the keywords and phrases that matter most to individuals seeking a voice restoration device. From “electronic larynx” to “speech aid” and “artificial larynx,” this product is optimized to ensure that it reaches those who need it most. Trusted by Professionals: Speech language pathologists recognize the Romet R120 as a reliable and effective tool for laryngectomees. With its exceptional performance and user-friendly design, it has become a sought-after choice among professionals and individuals alike. Restoring speech to over 20 countries: The R120 has helped laryngectomees speak in over 20 countries! Unlock the power of your voice with the Romet R120 Electronic Larynx. Regain your ability to communicate effortlessly, connect with loved ones, and thrive in social settings.
Who Else Makes It
Registered in Tianjin.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tianjin Tairuibosi Medical Appliance Co., Ltd. | Tianjin | Tianjin | Private-label distributor | 30 |
Record
| Listed by | Fountain Head Marketing Inc, United States |
|---|---|
| FDA product code | ESE |
| Device type | Larynx, Artificial (Battery-Powered) |
| Device class | Class 1 |
| Regulation | 21 CFR 874.3375 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-11-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Handling environment humidity 20 to 80 % RH; Handling environment temperature 15 to 32 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R120 | In distribution | |
| R210 | In distribution | |
| R310 | In distribution | |
| R700 | In distribution | |
| R600 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TruTone Plus® Electrolarynx | Griffin Laboratories | 7 |
| SolaTone Plus™ Electrolarynx | Griffin Laboratories | 6 |
| TruTone® Electrolarynx | Griffin Laboratories | 6 |
| TruTone Emote® Electrolarynx | Griffin Laboratories | 6 |
| SolaTone® Electrolarynx | Griffin Laboratories | 6 |
| Blom-Singer | Ent Solutions LLC | 4 |
| TeliTalk™ Electrolarynx | Griffin Laboratories | 4 |
| SolaTone Lite® Electrolarynx | Griffin Laboratories | 2 |
| Parlez Electrolarynx | Elogio Speech Technologies LLC | 2 |
| Liberty® Electrolarynx | Griffin Laboratories | 1 |
| Provox SolaTone Plus | Atos Medical AB | 1 |
| Provox TruTone Plus | Atos Medical AB | 1 |
Showing 12 of 15. All products under Larynx, Artificial (Battery-Powered)
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.