Identity
- Trade Name
- Accent 1400 TouchGuide 4 Location FDA UDI
- Generic Name
- Voice synthesizer/digitizer FDA UDI
- Device Name
- TouchGuides are made from clear polycarbonate material and precisely engineered to help guide the user’s touch to targeted icons on the screen and reduce accidental activations. TouchGuides allow the Accent 1400 to be set up to accommodate a wide range of cognitive and motor skills. Using the TouchGuide with the 1400 requires the device frame that came with the 1400. If a replacement frame is needed please go to 1400 Device Frame. FDA UDI
- Model / Reference
- 17341-4 FDA UDI
- Description
- TouchGuides are made from clear polycarbonate material and precisely engineered to help guide the user’s touch to targeted icons on the screen and reduce accidental activations. TouchGuides allow the Accent 1400 to be set up to accommodate a wide range of cognitive and motor skills. Using the TouchGuide with the 1400 requires the device frame that came with the 1400. If a replacement frame is needed please go to 1400 Device Frame. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858526006118 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Voice synthesizer/digitizer
Accent 1400 TouchGuide 4 Location by Prentke Romich Company — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Prentke Romich Company
Sources (2)
- FDA UDI 40f49d31-9686-4982-a089-76480b557e0b 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026