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United States·US-MF-000018695
Last updated September 17, 2026
What PRENTKE ROMICH COMPANY makes
Prentke Romich Company manufactures voice synthesizers and digitizers, including devices such as PRC-Saltillo, Nova Chat, PRC Look™, NuPoint, Via®Mini, PRiO 84 Location Keyguard, Touch Chat, and Chat Fusion.
The company's devices are classified as Class I and Class II medical devices and are listed in the EUDAMED and FDA UDI registries; the company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What type of devices does Prentke Romich Company manufacture?
Prentke Romich Company manufactures voice synthesizers and digitizers, as indicated by the device categories listed in the data. These include products such as PRC-Saltillo, Nova Chat, PRC Look™, NuPoint, Via®Mini, PRiO 84 Location Keyguard, Touch Chat, and Chat Fusion, which are examples of voice synthesizers and digitizers used for communication assistance.
Where is Prentke Romich Company based?
Prentke Romich Company is based in the United States, as explicitly stated in the COMPANY and COUNTRY fields of the provided data. The company's location is specified as US, confirming its headquarters or primary operations are located within the United States.
In which regulatory registries are Prentke Romich Company's devices listed?
Prentke Romich Company's devices are listed in the EUDAMED and FDA UDI registries, as stated in the LISTED IN field of the data. This means the devices have been entered into these regulatory systems for tracking and identification purposes, though this does not imply approval or clearance of the devices or the company itself.
How are Prentke Romich Company's devices classified in terms of medical device risk?
Prentke Romich Company's devices are classified as Class I and Class II medical devices, according to the DEVICE CLASSES field in the provided data. This classification reflects the level of regulatory control required based on risk, with Class I being low risk and Class II being moderate risk, though individual devices may vary in their specific class assignment.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 1022, Heyl Rd, Wooster, United States
- Website
- www.prc-saltillo.com/
- —
- —
- [email protected]
- Phone
- +1 330 262 1984
- PRRC Contact
- Beth Mulcahy
- EUDAMED SRN
- US-MF-000018695
- FDA FEI Number
- 3010819851
- DUNS Number
- 080143399
Catalogue (244)
Page 2 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Nova Chat | NC10.5-48-KG | FDA UDI | Class II | Active |
| Touch Chat | TC8.2-48-KG | FDA UDI | Class II | Active |
| Touch Chat | TC8.2-KIT-KG | FDA UDI | Class II | Active |
| Touch Chat Express | TCE8.2 | FDA UDI | Class II | Active |
| Nova Chat | NC10.4-60-KG | FDA UDI | Class II | Active |
| Nova Chat | NC8.3-42-KG | FDA UDI | Class II | Active |
| Accent 1400 | ACN1400 | FDA UDI | Class II | Active |
| Chat Fusion | CF10.1-15-KG | FDA UDI | Class II | Active |
| PRC-Saltillo | 19232 | FDA UDI | Class II | Active |
| Chat Fusion | CF10.1 | FDA UDI | Class II | Active |
| Nova Chat | NC8.2-KIT-KG | FDA UDI | Class II | Active |
| Nova Chat | NC12.1-15-KG | FDA UDI | Class II | Active |
| PRiO-mini | PRiO-mini | FDA UDI | Class II | Active |
| Saltillo | NC10.6-KIT-KG | FDA UDI | Class II | Active |
| TouchChat | TC10.1-KIT-KG | FDA UDI | Class II | Active |
| Nova Chat | NC12.1-108-KG | FDA UDI | Class II | Active |
| Accent 1000 | ACN1000-30 | FDA UDI | Class II | Active |
| NOVA Chat | NC8.3-KIT-KG | FDA UDI | Class II | Active |
| Nova Chat | NC8.2-108-KG | FDA UDI | Class II | Active |
| Nova Chat | NC12.1-20-KG | FDA UDI | Class II | Active |
| Nova Chat | NC8.3-60-KG | FDA UDI | Class II | Active |
| Freedom Switch | FS-2 | FDA UDI | Class II | Active |
| PRC-Saltillo | Via™Air 10 | FDA UDI | Class II | Active |
| Chat Fusion | CF8.1-15-KG | FDA UDI | Class II | Active |
| Freedom Switch | FS | FDA UDI | Class II | Unknown |
| Chat Point | CP | FDA UDI | Class II | Active |
| PRiO-mini 84 Location Keyguard | 17656 | FDA UDI | Class II | Active |
| PRC-Saltillo | 19232-25 | FDA UDI | Class II | Active |
| Via®Mini | 19663-84 | FDA UDI | Class II | Active |
| Chat Fusion | CF8.1-60-KG | FDA UDI | Class II | Active |
| Nova Chat | NC10.4-KIT-KG | FDA UDI | Class II | Active |
| NOVA Chat | NC8.3 | FDA UDI | Class II | Unknown |
| Nova Chat | NC12.1-60-KG | FDA UDI | Class II | Active |
| PRC-Saltillo | 19232-84 | FDA UDI | Class II | Active |
| Nova Chat | NC10.5-KIT-KG | FDA UDI | Class II | Active |
| Nova Chat | NC8.2-15-KG | FDA UDI | Class II | Active |
| Saltillo | VC7.1 | FDA UDI | Class II | Active |
| Touch Chat | TC8.2-30-KG | FDA UDI | Class II | Active |
| TouchChat Express | TCE10.1 | FDA UDI | Class II | Active |
| Via®Mini | 19662-25 | FDA UDI | Class II | Active |
| Touch Chat | TC8.2-80-KG | FDA UDI | Class II | Active |
| Nova Chat | NC8.2-20-KG | FDA UDI | Class II | Active |
| Chat Fusion | CF10.1-108-KG | FDA UDI | Class II | Active |
| Via®Mini | 19663-60 | FDA UDI | Class II | Active |
| Chat Fusion | CF8.1-42-KG | FDA UDI | Class II | Active |
| Nova Chat | NC10.5-42-KG | FDA UDI | Class II | Active |
| PRC-Saltillo | AS | FDA UDI | Class II | Active |
| Accent 800 | ACN800-30 | FDA UDI | Class II | Active |
| PRC Look™ | PRCL-1.1 | FDA UDI | Class II | Active |
| Touch Chat | TC8.2-42-KG | FDA UDI | Class II | Active |
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