DEVICE: PRiO (00858526006576)
Device Identifier (DI) Information
PRiO
PRiO
In Commercial Distribution
PRENTKE ROMICH COMPANY
PRiO
In Commercial Distribution
PRENTKE ROMICH COMPANY
The PRiO is an iPad based communication tool featuring the iPad Air and the popular LAMP Words for Life (WFL) Vocabulary.
LAMP WFL is a full vocabulary communication app that combines the power of UNITY with the principles and strategies of Language Acquisition through Motor Planning (LAMP). The WFL vocabulary is appropriate for individuals with a wide range of language and communication skills.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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17187 | Voice synthesizer/digitizer |
An assistive device designed to deliver voice output based either in the reproduction of previously-recorded natural speech and/or on an electronic synthesized voice following a pre-established set of pronunciation rules. It typically consists of an electronic unit with a keyboard and screen; the keyboard may include letters, symbols, or both. The device is often customized to meet the user?s needs and is mostly used by patients with disabilities that partially or totally impair voice capabilities, including chronic progressive diseases.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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ILQ | System, Communication, Powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Humidity: less than 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between -20 and 50 Degrees Celsius |
Handling Environment Temperature: between 0 and 45 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Weight: 1.9 Pound |
Device Record Status
48537c73-89ce-4359-8ba6-b4f69d03e266
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-262-1984
info@prentrom.com
info@prentrom.com