FDA.report

Inspire XL

Primary DI
B660RMIXL0
Brand
Inspire XL
Company
RM SPEECH
Model
RMIXL
Device description
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Windows operating system.
Published
2019-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
B660RMIXL0PrimaryHIBCC0

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
(877) 494-4956support@rmspeech.com

Regulatory Flags

DUNS number
949608546
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

Primary DIBrandModelCatalogPublished
B660RMNXL0Nuvo XLRMNXL2025-02-28
B660RMILC0Inspire LiteRMILC2023-05-23
B660RMNS0Nuvo SRMNS2022-09-02
B660RMNXS0Nuvo XSRMNXS2022-09-02
B660RMI0InspireRMI2018-07-18
B660RMN0NuvoRMN2018-07-18

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