FDA.reportPublic FDA data

Lenire

Primary DI
05391540581018
Brand
Lenire
Company
NEUROMOD DEVICES LIMITED
Model
TP-101
Device description
Lenire Tonguetip
Published
2023-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QVNCombined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QVNCombined Acoustic And Electrical External Stimulation Device For The Relief Of TinnitusEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN210033000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN210033000Lenire Tinnitus Treatment DeviceNeuromod Devices Limited2023-03-06QVN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391540581018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391540581018053915405810185391540581018

GMDN Terms#

Term, Definition table
TermDefinition
Tinnitus therapy translingual electrical stimulation electrode arrayA device designed to conduct electrical pulses from a system generator to the tongue as part of a bimodal neuromodulation therapy for tinnitus. It includes an electrode array and is intended to be placed in the mouth during therapy. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985051113
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391540580141LenireCR-2012026-02-20
05391540580158LenireTP-1012026-02-20
05391540582015LenireCR-2012023-05-19
05391540580011LenireTP-1012023-05-19
05391540580028LenireCR-2012023-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391540580141LenireNEUROMOD DEVICES LIMITEDQVN2026-02-20
05391540580158LenireNEUROMOD DEVICES LIMITEDQVN2026-02-20
05391540582015LenireNEUROMOD DEVICES LIMITEDQVN2023-05-19
05391540580011LenireNEUROMOD DEVICES LIMITEDQVN2023-05-19
05391540580028LenireNEUROMOD DEVICES LIMITEDQVN2023-05-19