FDA.reportPublic FDA data

PRC Look™

Primary DI
00858526006736
Brand
PRC Look™
Company
PRENTKE ROMICH COMPANY
Model
PRCL-1.1
Device 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."
Published
2021-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILQSystem, Communication, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILQSystem, Communication, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858526006736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858526006736008585260067368585260067360858526006736

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Weight0.1Pound

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-262-1984info@prentrom.com

Regulatory Flags#

DUNS number
080143399
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816486021695Via Pro 25 Loc TG19233-25-A2026-04-23
00816486021701Via Pro 42 Loc TG19233-42-A2026-04-23
00816486021718Via Pro 60 Loc TG19233-60-A2026-04-23
00816486021725Accent-80017348-KIT2026-04-22
00816486021732Accent-100017345-KIT2026-04-22
00816486021749Accent-140017342-KIT2026-04-22
00816486021640PRC-SaltilloPredictable App2026-03-10
00816486021572LAMP WFL Discover AppLAMP WFL Discover204262025-10-13
00816486021626Unity AAC AppUnity AAC204252025-10-13
00816486021633Unity Discover AppUnity2025-08-05
00816486021541PRC-SaltilloVia Nano 6.120170-102025-02-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812324018315Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018322Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018339Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018346Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018353Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018360Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018377Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018384Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018391Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018407Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018414Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018421Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018438Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018445Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018452Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018469Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018476Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018483Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018490Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018506Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018513Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00887761943131Voalte Nurse CallHILL-ROM, INC.ILQ2026-09-28
00840828197014RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-08-18
00840828196895PAD-CORDED,UNDER SEAT,10"X15",92" CORDCURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-23
00840828196901PAD WIRELESS, UNDER SEAT, 10"X15"CURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-23
00840828196710P4600 90°,S4600,1 FT,R6,PS BREAKAWAYCURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08
008408281967274600,R6,BASIC,2 LT,DVCURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08
008408281967344600,R6,ENH,2 LT,DVCURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08
00840828196741RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08
00840828196765RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08