Identity
- Trade Name
- PRC Look™ FDA UDI
- Generic Name
- Voice synthesizer/digitizer FDA UDI
- Device Name
- The PRC Look™ Tracking System is setting a new standard for eye gaze systems. Compatible with the Accent 1400 and Accent 1000, now you can access the full communication & computing power with just your eyes! The PRC Look™ Tracking System attaches quickly to the Accent 1400 or Accent 1000 device to give users full visual control of the device. Keys are "selected" by gazing for a specified period of time to generate speech. FDA UDI
- Model / Reference
- PRCL-1 FDA UDI
- Description
- The PRC Look™ Tracking System is setting a new standard for eye gaze systems. Compatible with the Accent 1400 and Accent 1000, now you can access the full communication & computing power with just your eyes! The PRC Look™ Tracking System attaches quickly to the Accent 1400 or Accent 1000 device to give users full visual control of the device. Keys are "selected" by gazing for a specified period of time to generate speech. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858526006699 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — .10 Pound FDA UDI
Category: Voice synthesizer/digitizer
PRC Look™ by Prentke Romich Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 1f7172ed-4ea8-49b4-9647-b6f0cb73c9a1 36 fields · synced May 31, 2026