FDA.report

Accent 1400 Keyguard 15 Location

Primary DI
00858526006200
Brand
Accent 1400 Keyguard 15 Location
Company
PRENTKE ROMICH COMPANY
Model
17342-15
Device description
The keyguard allows the Accent 1400 to be set up for specific locations to accommodate a wide range of cognitive and motor skills. Using the keyguard with the 1400 requires the device frame that came with the 1400. If a replacement frame is needed please go to 1400 Device Frame.
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
00858526006200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00858526006200008585260062008585260062000858526006200

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.

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
false
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

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