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.…

Registry build 21.09.26

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.

1manufacturer
5catalogue numbers in this listing

Who Else Makes It

Registered in Tianjin.

Chinese manufacturers registered for FDA product code ESE
Manufacturer City Province Registered as Device types
Tianjin Tairuibosi Medical Appliance Co., Ltd. Tianjin Tianjin Private-label distributor 30

Record

Regulatory record for Romet
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

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 numbers for Romet
Catalogue number Size Status
R120 In distribution
R210 In distribution
R310 In distribution
R700 In distribution
R600 In distribution

Same Product Code

Other products under the same FDA 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer