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Sign in to claim this brandRM SPEECH
US
Last updated May 27, 2026
What RM SPEECH makes
RM Speech manufactures voice synthesizer and digitizer devices designed to assist individuals with speech impairments. Their product line includes a range of systems such as the Nuvo series (Nuvo XL, Nuvo XS, Nuvo S, and Nuvo) and the Inspire series (Inspire, Inspire XL, and Inspire Lite), which provide text-to-speech functionality and customizable voice options.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. RM Speech operates as a US-based manufacturer, adhering to applicable regulatory standards for medical devices in the country.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does RM Speech manufacture?
RM Speech specializes in voice synthesizer and digitizer devices. These products convert text into speech, helping individuals with speech impairments communicate more effectively. Examples include the Nuvo and Inspire series, which offer customizable voice options and text-to-speech functionality.
Where is RM Speech based, and how does that affect its devices?
RM Speech is based in the United States, which means its devices are designed and manufactured in compliance with US regulatory standards. This includes adherence to FDA requirements for medical devices, ensuring quality, safety, and performance for its voice synthesizer and digitizer products.
Which regulatory registries list RM Speech’s devices?
RM Speech’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the US, ensuring transparency and traceability for products like the Nuvo and Inspire series.
How are RM Speech’s devices classified under FDA regulations?
RM Speech’s voice synthesizer and digitizer devices fall under Class II classification by the FDA. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- rmspeech.com
- —
- —
- [email protected]
- Phone
- (877) 494-4956
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 949608546
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Nuvo XL | RMNXL | FDA UDI | Class II | Active |
| Inspire | RMI | FDA UDI | Class II | Active |
| Inspire XL | RMIXL | FDA UDI | Class II | Active |
| Nuvo XS | RMNXS | FDA UDI | Class II | Active |
| Nuvo S | RMNS | FDA UDI | Class II | Active |
| Inspire Lite | RMILC | FDA UDI | Class II | Active |
| Nuvo | RMN | FDA UDI | Class II | Active |
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