Identity
- Trade Name
- NovaChat FDA UDI
- Generic Name
- Voice synthesizer/digitizer FDA UDI
- Device Name
- NovaChat 10.7 Set of multiple Keyguards FDA UDI
- Model / Reference
- 19528 FDA UDI
- Description
- NovaChat 10.7 Set of multiple Keyguards FDA UDI
Identifiers
- Catalog Number
- NC10.7-KG KIT FDA UDI
- Primary DI / UDI-DI
- 00816486021244 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
- 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Voice synthesizer/digitizer
NovaChat by Prentke Romich Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Voice synthesizer/digitizer.
- Lingraphica — LINGRAPHICARE AMERICA, INC. · Class II
- G13 — SMARTBOX ASSISTIVE TECHNOLOGY INC · Class II
- Lingraphica — LINGRAPHICARE AMERICA, INC. · Class II
- NeuroSwitch — CONTROL BIONICS INCORPORATED · Class II
- Talk Pad — Talk To ME Technologies, LLC · Class II
- L10 — SMARTBOX ASSISTIVE TECHNOLOGY INC · Class II
- WinSlate — FORBES REHAB SERVICES INC. · Class II
- G16 — SMARTBOX ASSISTIVE TECHNOLOGY INC · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prentke Romich Company
Sources (1)
- FDA UDI 149ce754-aa4d-4707-9403-d299ca0e919e 35 fields · synced May 30, 2026