FDA.reportPublic FDA data

Tinearity Adapters

Primary DI
07350136210020
Brand
Tinearity Adapters
Company
Duearity AB
Model
G1
Catalog number
6042
Published
2023-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
KLWMasker, Tinnitus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLWMasker, TinnitusEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223694000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223694000Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)Duearity AB2023-06-30KLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350136210020PrimaryGS10
07350136210051Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350136210020073501362100207350136210020
07350136210051073501362100517350136210051

GMDN Terms#

Term, Definition table
TermDefinition
Bone-conduction tinnitus maskerA battery-powered acoustic device designed to provide ultrasonic broadband noise and/or sweep-frequency stimuli noise of sufficient intensity and bandwidth to mask tinnitus (a ringing sound in the ear or internal head noises) by neutralizing a patient’s perception of the symptoms for temporary relief. It consists of an out-of-ear miniature generator/amplifier with a piezoelectric element which conducts the noise to the inner ear across the skin and via the mastoid bone; it may be contained in a case worn behind-the-ear (BTE), attached to a headband, or hand-held by the user against the skin over the mastoid bone.

Regulatory Flags#

DUNS number
353427191
Device count
3
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350136210099TinearityG161032023-07-28
07350136210051Tinearity AdaptersG160422023-07-28
07350136210075TinearityG161032023-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880295719SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295726SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295733SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295740SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295788SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295795SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295849SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295856SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295900SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295917SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295986SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880296013SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880296044SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880296075SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880296105SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880214345Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214369Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214376Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214383Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214390Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214413Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214420Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214543Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214567Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214574Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214581Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214598Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214611Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214628Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219425Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28