Question 1

What type of devices does Prentke Romich Company manufacture?

Accepted Answer

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.

Question 2

Where is Prentke Romich Company based?

Accepted Answer

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.

Question 3

In which regulatory registries are Prentke Romich Company's devices listed?

Accepted Answer

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.

Question 4

How are Prentke Romich Company's devices classified in terms of medical device risk?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Nova Chat	NC8.3-25-KG	FDA UDI	Class II	Active
Accent 1400 TouchGuide 4 Location	17341-4	FDA UDI	Class II	Active
Chat Fusion	CF8.1-80-KG	FDA UDI	Class II	Active
Touch Chat	TC10.1-80-KG	FDA UDI	Class II	Active
PRiO	PRiO	FDA UDI	Class II	Active
Saltillo	19254	FDA UDI	Class II	Active
Chat Fusion	CF10.1-42-KG	FDA UDI	Class II	Active
Nova Chat	NC8.3-80-KG	FDA UDI	Class II	Active
Nova Chat	NC10.4	FDA UDI	Class II	Unknown
Nova Chat	NC12.1-42-KG	FDA UDI	Class II	Active
Chat Fusion	CF8.1-KIT-KG	FDA UDI	Class II	Active
Nova Chat	NC10.5-80-KG	FDA UDI	Class II	Active
Nova Chat	NC8.2-48-KG	FDA UDI	Class II	Active
Nova Chat	NC10.4-15-KG	FDA UDI	Class II	Active
Via®Mini	19663-42	FDA UDI	Class II	Active
Chat Fusion	CF10.1-80-KG	FDA UDI	Class II	Active
Via®Mini	19662-42	FDA UDI	Class II	Active
Touch Chat	TC10.1-42-KG	FDA UDI	Class II	Active
Chat Fusion	CF8.1-20-KG	FDA UDI	Class II	Active
Via®Mini	19663-25	FDA UDI	Class II	Active
Touch Chat	TC10.1-20-KG	FDA UDI	Class II	Active
PRC Look™	PRCL-2	FDA UDI	Class II	Active
Accent 1400 Thick Keyguard 84 Location	17342-84-XT	EUDAMEDFDA UDI	Class I	Active
Accent 1000 TouchGuide 8 Location	17344-8	EUDAMEDFDA UDI	Class I	Active
Accent 1000 Keyguard 28 Location	17345-28	EUDAMEDFDA UDI	Class I	Active
NovaChat	20066-25	EUDAMEDFDA UDI	Class I	Active
NovaChat 10.7 Keyguard 15 location	19528-15-A	EUDAMEDFDA UDI	Class I	Active
Dialogue	18312	EUDAMEDFDA UDI	Class I	Active
Saltillo	18626-4	EUDAMEDFDA UDI	Class I	Active
NovaChat	20066-42	EUDAMEDFDA UDI	Class I	Active
Accent 800 TouchGuide 84 Location	17347-84	EUDAMEDFDA UDI	Class I	Active
Accent 1400 Keyguard 28 Location	17342-28	EUDAMEDFDA UDI	Class I	Active
Accent 1400 TouchGuide 8 Location	17341-8	EUDAMEDFDA UDI	Class I	Active
Eloquence	19683	EUDAMEDFDA UDI	Class I	Active
Nova Chat 10.6 Keyguard 42 Location	18182-42-A	EUDAMEDFDA UDI	Class I	Active
NovaChat 10.7 Keyguard 20 location	19528-20-A	EUDAMEDFDA UDI	Class I	Active
Nova Chat 10.6 Keyguard 15 Location	18182-15-A	EUDAMEDFDA UDI	Class I	Active
Unity AAC App	20425	EUDAMED	Class I	Active
Nova Chat 10.6 Keyguard 48 Location	18182-48-A	EUDAMEDFDA UDI	Class I	Active
Accent 800 Keyguard 84 Location	17348-84	EUDAMEDFDA UDI	Class I	Active
Scanning Director	K944585	FDA 510(k)	Class II	Active
Light Talker	K925527	FDA 510(k)	Class II	Active
Walkertalker	K933207	FDA 510(k)	Class II	Active
Hospital/Home Environmental Control Syst/Hecs-1	K902664	FDA 510(k)	Class II	Active
Touch Talker	K914259	FDA 510(k)	Class II	Active
Liberator	K925387	FDA 510(k)	Class II	Active
Alpha Talker	K935317	FDA 510(k)	Class II	Active
Deltatalker With Infrared	K961306	FDA 510(k)	Class II	Active
Control 1 Environmental Control	K902206	FDA 510(k)	Class II	Active
Accent 800 TouchGuide 28 Location	17347-28	EUDAMEDFDA UDI	Class I	Active

PRENTKE ROMICH COMPANY

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