PRENTKE ROMICH COMPANY

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

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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 Fusion - 00816486020100 Catalog Number :

Device Description : 54 Location Keyguard for WordPower 108 file 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 - 00816486020117 Catalog Number :

Device Description : 54 Location Keyguard for WordPower 108 file for Chat Fusion 10.1

Device Class : 2

Duns Number: 080143399

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

Chat Fusion - 00816486020124 Catalog Number :

Device Description : 40 Location Keyguard for WordPower 80 file for Chat Fusion 10.1

Device Class : 2

Duns Number: 080143399

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

Chat Fusion - 00816486020131 Catalog Number :

Device Description : 60 Location Keyguard for Chat Fusion 10.1

Device Class : 2

Duns Number: 080143399

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

Chat Fusion - 00816486020148 Catalog Number :

Device Description : 48 Location Keyguard for Chat Fusion 10.1

Device Class : 2

Duns Number: 080143399

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

Chat Fusion - 00816486020155 Catalog Number :

Device Description : 42 Location Keyguard for Chat Fusion 10.1

Device Class : 2

Duns Number: 080143399

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

Chat Fusion - 00816486020162 Catalog Number :

Device Description : 20 Location Keyguard for Chat Fusion 10.1

Device Class : 2

Duns Number: 080143399

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

Chat Fusion - 00816486020179 Catalog Number :

Device Description : 15 Location Keyguard for Chat Fusion 10.1

Device Class : 2

Duns Number: 080143399

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

Chat Fusion - 00816486020186 Catalog Number :

Device Description : Set of 7 Keyguards for Chat Fusion 10.1 - 15 Location, 20 Location, 42 Location, Set of 7 Keyguards for Chat Fusion 10.1 - 15 Location, 20 Location, 42 Location, 48 Location, 60 Location, 40 Location for WordPower 80 file, and 54 Location for 108 WordPower

Device Class : 2

Duns Number: 080143399

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

Nova Chat - 00816486020193 Catalog Number :

Device Description : Nova chat 5.3 is a speech generating device with a 5 inch screen. The NC5.3 is Nova chat 5.3 is a speech generating device with a 5 inch screen. The NC5.3 is our smallest integrated communication system that offers the well-known Chat software on an Android platform. Like all "Chats," NOVA chat 5 offers a durable yet sleek portable design, with features that include a 5" display, multiple position capabilities, switch scanning, Social Chat, IVONA speech synthesizer, and many other Chat features.

Device Class : 2

Duns Number: 080143399

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

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