FDA.reportPublic FDA data

SERVOX digital XL

Primary DI
04040823006502
Brand
SERVOX digital XL
Company
Servona GmbH
Model
37575
Device description
The SERVOX® digital XL speech aid offers patients, who have lost their voice due to injury, illness or surgicalremoval of the larynx, the opportunity to quickly regain the ability to communicate.The SERVOX® digital XL can also be used by patients who are temporarily voiceless due to a tracheotomy, who have to protect their vocal folds due to illness or who are connected to a respirator.
Published
2021-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ESELarynx, Artificial (Battery-Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESELarynx, Artificial (Battery-Powered)Ear, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04040823006502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04040823006502040408230065024040823006502

GMDN Terms#

Term, Definition table
TermDefinition
Transcervical artificial larynxA battery-powered, speech-assistive device designed to be used by a person who has had their larynx removed (laryngectomy) to assist them in the reproduction of sounds similar to those produced by the vocal cords in normal speech. It is an externally-applied electromechanical device (also known as a neck-type artificial larynx) with a plastic or metal probe that generates a sound (i.e., tone); when the probe is held against the tissues of the neck (or cheek) the tone is transmitted to the mouth through the oropharynx. The appropriate movement of the lips, tongue, teeth, and jaw converts the tone into meaningful speech (i.e., modulates the tone).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
329895200
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860012896806Parlez ElectrolarynxElogio Speech Technologies LLCESE2026-06-09
00860012896875Parlez ElectrolarynxElogio Speech Technologies LLCESE2026-06-09
10850057368014Blom-SingerEnt Solutions LLCESE2023-12-18
10850057368021Blom-SingerEnt Solutions LLCESE2023-12-18
10850057368038Blom-SingerEnt Solutions LLCESE2023-12-18
10850057368007Blom-SingerEnt Solutions LLCESE2023-12-18
20850057368011Blom-SingerEnt Solutions LLCESE2023-12-18
20850057368028Blom-SingerEnt Solutions LLCESE2023-12-18
20850057368035Blom-SingerEnt Solutions LLCESE2023-12-18
00860009460508RometFountain Head Marketing Inc.ESE2023-11-15
00860009460515RometFountain Head Marketing Inc.ESE2023-11-15
00860009460522RometFountain Head Marketing Inc.ESE2023-11-15
00860009460539RometFountain Head Marketing Inc.ESE2023-11-15
00860009460546RometFountain Head Marketing Inc.ESE2023-11-15
00860009460591Blom-SingerFountain Head Marketing Inc.ESE2023-11-15
07331791015571Provox TruTone PlusAtos Medical ABESE2022-07-08
07331791015823Provox SolaTone PlusAtos Medical ABESE2022-07-08
07331791015830Provox TruTone EmoteAtos Medical ABESE2022-07-08
00813124010981TruTone Plus® ElectrolarynxGRIFFIN LABORATORIESESE2021-02-05
00813124010738TruTone Plus® ElectrolarynxGRIFFIN LABORATORIESESE2020-08-24
00813124010974TruTone Plus® ElectrolarynxGRIFFIN LABORATORIESESE2020-08-24
00813124010868TeliTalk™ ElectrolarynxGRIFFIN LABORATORIESESE2020-03-17
00813124010875TeliTalk™ ElectrolarynxGRIFFIN LABORATORIESESE2020-03-17
00813124010004TruTone® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010035SolaTone® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010097TruTone® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010103SolaTone Plus™ ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010110SolaTone Lite® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010127SolaTone Plus™ ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010134TruTone Plus® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23