PRC Look™ - The PRC Look™ Tracking System is setting a new - PRENTKE ROMICH COMPANY

Duns Number:080143399

Device Description: The PRC Look™ Tracking System is setting a new standard for eye gaze systems. Compatible w 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.

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More Product Details

Catalog Number

-

Brand Name

PRC Look™

Version/Model Number

PRCL-1.1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

ILQ

Product Code Name

System, Communication, Powered

Device Record Status

Public Device Record Key

46500247-2f77-4f13-8b6a-f27ecfcbcd46

Public Version Date

July 22, 2021

Public Version Number

1

DI Record Publish Date

July 14, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRENTKE ROMICH COMPANY" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 198