PRENTKE ROMICH COMPANY

Address:1022 Heyl Rd,WOOSTER,OH,44691,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Communication, Powered (ILQ) (10)

Premarket Exempt

Yes

Clear

Chat Point - 00816486020001 Catalog Number :

Device Description : Head pointing for Chat Fusion

Device Class : 2

Duns Number: 080143399

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

Chat Fusion - 00816486020018 Catalog Number :

Device Description : Chat Fusion 8.1 is a speech generating device with an 8 inch screen. Fusion offe Chat Fusion 8.1 is a speech generating device with an 8 inch screen. Fusion offers multiple access methods including Chat Point (optional headpointing), a front and rear camera, and extended battery life. Single or dual switch and advanced scanning features are incorporated into the device as well. Additionally, a wheelchair mounting plate has been included for your convenience.

Device Class : 2

Duns Number: 080143399

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

Chat Fusion - 00816486020025 Catalog Number :

Device Description : Chat Fusion 10.1 is a speech generating device with a 10 inch screen. Chat Fusio Chat Fusion 10.1 is a speech generating device with a 10 inch screen. Chat Fusion offers wireless charging capabilities using a docking station, multiple access methods including optional headpointing and advanced scanning, and many other features!

Device Class : 2

Duns Number: 080143399

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

Chat Fusion - 00816486020032 Catalog Number :

Device Description : Set of 7 Keyguards for Chat Fusion 8.1 - 15 Location, 20 Location, 42 Location Set of 7 Keyguards for Chat Fusion 8.1 - 15 Location, 20 Location, 42 Location, 48 Location, 60 Location, 40 Location for WordPower 80 file and 54 Location for WordPower 108 file.

Device Class : 2

Duns Number: 080143399

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

Chat Fusion - 00816486020049 Catalog Number :

Device Description : 15 Location keyguard for Chat Fusion 8.1

Device Class : 2

Duns Number: 080143399

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

Chat Fusion - 00816486020056 Catalog Number :

Device Description : 20 Location keyguard for Chat Fusion 8.1

Device Class : 2

Duns Number: 080143399

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

Chat Fusion - 00816486020063 Catalog Number :

Device Description : 42 Location Keyguard for Chat Fusion 8.1

Device Class : 2

Duns Number: 080143399

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

Chat Fusion - 00816486020070 Catalog Number :

Device Description : 48 Location Keyguard for Chat Fusion 8.1

Device Class : 2

Duns Number: 080143399

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

Chat Fusion - 00816486020087 Catalog Number :

Device Description : 60 Location keyguard for Chat Fusion 8.1

Device Class : 2

Duns Number: 080143399

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

Chat Fusion - 00816486020094 Catalog Number :

Device Description : 40 Location for WordPower 80 file Keyguard for Chat Fusion 8.1

Device Class : 2

Duns Number: 080143399

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

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