Identity
- Trade Name
- Nova Chat FDA UDI
- Generic Name
- Voice synthesizer/digitizer FDA UDI
- Device Name
- Nova Chat 8.2 is a speech generating device with an 8 inch screen. NOVA chat 8 is a communication system that offers the well-known Chat software on an Android platform. Like all "Chats," NOVA chat 8 offers a durable yet sleek portable design, with features that include an 8" display, switch scanning, Social Chat, IVONA speech synthesizer, and many other Chat features. FDA UDI
- Model / Reference
- NC8.2 FDA UDI
- Description
- Nova Chat 8.2 is a speech generating device with an 8 inch screen. NOVA chat 8 is a communication system that offers the well-known Chat software on an Android platform. Like all "Chats," NOVA chat 8 offers a durable yet sleek portable design, with features that include an 8" display, switch scanning, Social Chat, IVONA speech synthesizer, and many other Chat features. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816486020209 FDA UDI
- FDA Product Code
- ILQ FDA UDI
- GMDN Term
- Voice synthesizer/digitizer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3710 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 1.35 Pound FDA UDI
Nova Chat by Prentke Romich Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Prentke Romich Company
Sources (1)
- FDA UDI 9802aa5e-00d2-4565-b654-dac478bb0619 36 fields · synced May 30, 2026