FDA.reportPublic FDA data

Lenire

Primary DI
05391540582015
Brand
Lenire
Company
NEUROMOD DEVICES LIMITED
Model
CR-201
Device description
Lenire Tinnitus Treatment Device
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
05391540582015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391540582015053915405820155391540582015

GMDN Terms#

Term, Definition table
TermDefinition
Tinnitus therapy auditory/translingual electrical stimulation systemAn electrically-powered assembly of devices designed to treat tinnitus through bimodal neuromodulation of the brain, involving simultaneous application of electrical pulses to the tongue and delivery of specific sounds to the auditory system. It includes a system generator and a tongue applicator with integrated electrodes; it is intended to be used with headphones which might be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985051113
Device count
1
Serial number
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
05391540581018LenireTP-1012023-05-19
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
05391540581018LenireNEUROMOD DEVICES LIMITEDQVN2023-05-19
05391540580011LenireNEUROMOD DEVICES LIMITEDQVN2023-05-19
05391540580028LenireNEUROMOD DEVICES LIMITEDQVN2023-05-19