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
NovaChat 8.4 Keyguard 48 locations	19254-48-A	EUDAMEDFDA UDI	Class I	Active
Accent 1400 TouchGuide 60 Location	17341-60	EUDAMEDFDA UDI	Class I	Active
Accent 1400 TouchGuide 36 Location	17341-36	EUDAMEDFDA UDI	Class I	Active
NovaChat	20062-42	EUDAMEDFDA UDI	Class I	Active
Accent 1000 TouchGuide 144 Location	17344-144	EUDAMEDFDA UDI	Class I	Active
NovaChat 8.4 Keyguard 25 locations	19254-25-A	EUDAMEDFDA UDI	Class I	Active
NovaChat 10.7 TouchGuide 60 location	19584-60-A	EUDAMEDFDA UDI	Class I	Active
Accent 1400 TouchGuide 84 Location	17341-84	EUDAMEDFDA UDI	Class I	Active
Accent 1000 Keyguard 36 Location	17345-36	EUDAMEDFDA UDI	Class I	Active
Accent 800 Keyguard 45 Location	17348-45	EUDAMEDFDA UDI	Class I	Active
Predictable	20606	EUDAMED	Class I	Active
Accent 800 TouchGuide 36 Location	17347-36	EUDAMEDFDA UDI	Class I	Active
Accent 1400 Keyguard 36 Location	17342-36	EUDAMEDFDA UDI	Class I	Active
Accent 1000 TouchGuide 36 Location	17344-36	EUDAMEDFDA UDI	Class I	Active
Accent 800 TouchGuide 60 Location	17347-60	EUDAMEDFDA UDI	Class I	Active
Quasselkiste	19285-2	EUDAMEDFDA UDI	Class I	Active
Nova Chat 10.6 Keyguard 25 Location	18182-25-A	EUDAMEDFDA UDI	Class I	Active
NovaChat 8.4 Keyguard 15 location	19254-15-A	EUDAMEDFDA UDI	Class I	Active
Nova Chat 10.6 Keyguard 108 Location	18182-108-A	EUDAMEDFDA UDI	Class I	Active
NovaChat 8.4 Keyguard 24 locations Icons	19254-24I-A	EUDAMEDFDA UDI	Class I	Active
NovaChat12.1	NC12.1	EUDAMEDFDA UDI	Class I	Active
NovaChat 10.7 Keyguard 60 location	19528-60-A	EUDAMEDFDA UDI	Class I	Active
Accent 1000 Tactile Keyguide 84 Location	18711-84	EUDAMEDFDA UDI	Class I	Active
Accent 800 Keyguard 15 Location	17348-15	EUDAMEDFDA UDI	Class I	Active
Saltillo	18626	EUDAMEDFDA UDI	Class I	Active
Accent 800 Keyguard 36 Location	17348-36	EUDAMEDFDA UDI	Class I	Active
NovaChat 8.4 Keyguard 20 locations	19254-20-A	EUDAMEDFDA UDI	Class I	Active
Accent 800 Keyguard 8 Location	17348-8	EUDAMEDFDA UDI	Class I	Active
NovaChat	20066-84	EUDAMEDFDA UDI	Class I	Active
Accent 1000 Keyguard 84 Location	17345-84	EUDAMEDFDA UDI	Class I	Active
Lamp	16659-2	EUDAMEDFDA UDI	Class I	Active
NovaChat 8.4 Keyguard 60 location Icons	19254-60I-A	EUDAMEDFDA UDI	Class I	Active
Via Mini 8.1	F19557-10	EUDAMEDFDA UDI	Class I	Active
Accent 1400	ACN1400-30	EUDAMEDFDA UDI	Class I	Active
LAMP WFL Discover APP	16659-3	EUDAMED	Class I	Active
Accent 1400 Keyguard 144 Location	17342-144	EUDAMEDFDA UDI	Class I	Active
Accent 1000 Keyguard 45 Location	17345-45	EUDAMEDFDA UDI	Class I	Active
NovaChat	NC5.4	EUDAMEDFDA UDI	Class I	Active
NovaChat	20062-60	EUDAMEDFDA UDI	Class I	Active
Accent 800	ACN800-40	EUDAMEDFDA UDI	Class I	Active
NovaChat 8.4 Keyguard 60 locations	19254-60-A	EUDAMEDFDA UDI	Class I	Active
Accent 1000 TouchGuide 45 Location	17344-45	EUDAMEDFDA UDI	Class I	Active
Accent 1400 Keyguard 60 Location	17342-60	EUDAMEDFDA UDI	Class I	Active
NovaChat 10.7 TouchGuide 42 location	19584-42-A	EUDAMEDFDA UDI	Class I	Active

PRENTKE ROMICH COMPANY

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