FDA.report

PRiO

Primary DI
00858526006576
Brand
PRiO
Company
PRENTKE ROMICH COMPANY
Model
PRiO
Device description
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.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
ILQSystem, Communication, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
ILQSystem, Communication, PoweredPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00858526006576PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00858526006576008585260065768585260065760858526006576

GMDN Terms

TermDefinition
Voice synthesizer/digitizerAn 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.

Device Sizes

TypeValueUnit
Weight1.9Pound

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius45 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
800-262-1984info@prentrom.com

Regulatory Flags

DUNS number
080143399
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00816486021015SaltilloTouchChat App186262023-11-08
00816486021022SaltilloTouchChat App18626-02023-11-08
00816486021039SaltilloTouchChat App18626-12023-11-08
00816486021053SaltilloTouchChat App18626-42023-11-08
00816486021060PRCQuasselkiste App19285-22023-11-08
00816486021077PRCLAMP WFL (UK) App16659-22023-11-08
00816486021084PRCLAMP WFL App166592023-11-08
00816486021183PRC-SaltilloDialogue App183122023-11-08
00816486021237EloquenceEloquence App196832023-11-08
00816486021367PRC-SaltilloDiscover App19285-92023-11-08
00816486021473NovaChat20066-422023-10-11
00816486021480NovaChat20066-252023-10-11
00816486021497NovaChat20066-602023-10-11
00858526006941NovaChat20062-152023-10-11
00858526006958NovaChat20062-202023-10-11
00858526006965NovaChat20062-252023-10-11
00858526006972NovaChat20062-422023-10-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00860014667602MedMinder Systems, Inc.MEDMINDER SYSTEMS, INC.ILQ2026-03-23
00840828196123RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-11
00840828196130RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-11
00840828196147RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-11
00840828196154RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-11
00816486021640PRC-SaltilloPRENTKE ROMICH COMPANYILQ2026-03-10
00840828196093RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-04
00840828196024RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-03
00840828196048RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-03
00840828195966ZEPHYR,800,10,PUFF,JERON 680CURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-11
00840828195973ZEPHYR,800,10,SIP=N,PUFF=TV,JERON 680CURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-11
00840828195980ZEPHYR,800,10,SIP=TV,PUFF=N,JERON 680CURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-11
00840828195997ZEPHYR,800,10,SIP,JERON 680CURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-11
00840828195911RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-03
00812324018308Series 8 Anacom MedTekAnacom MedtekILQ2026-01-27
00812324018094Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018100Series 7 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018117Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018124Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018131Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018148Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018155Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018162Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018179Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018186Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018193Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018209Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018216Series 7 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018223Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018230Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22