FDA.reportPublic FDA data

Tinearity

Primary DI
07350136210099
Brand
Tinearity
Company
Duearity AB
Model
G1
Catalog number
6103
Published
2023-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
07350136210075Direct MarkingGS10
07350136210099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350136210075073501362100757350136210075
07350136210099073501362100997350136210099

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
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350136210020Tinearity AdaptersG160422023-07-28
07350136210051Tinearity AdaptersG160422023-07-28
07350136210075TinearityG161032023-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708296394029BeltoneGn Hearing A/SKLW2026-10-05
05708296394036BeltoneGn Hearing A/SKLW2026-10-05
05708296394098BeltoneGn Hearing A/SKLW2026-10-05
05708296394104BeltoneGn Hearing A/SKLW2026-10-05
05708296394111BeltoneGn Hearing A/SKLW2026-10-05
05708296394128BeltoneGn Hearing A/SKLW2026-10-05
05708296394135BeltoneGn Hearing A/SKLW2026-10-05
05708296394197BeltoneGn Hearing A/SKLW2026-10-05
05708296394203BeltoneGn Hearing A/SKLW2026-10-05
05708296394210BeltoneGn Hearing A/SKLW2026-10-05
05708296394487BeltoneGn Hearing A/SKLW2026-10-05
05708296394494BeltoneGn Hearing A/SKLW2026-10-05
05708296394555BeltoneGn Hearing A/SKLW2026-10-05
05708296394562BeltoneGn Hearing A/SKLW2026-10-05
05708296394579BeltoneGn Hearing A/SKLW2026-10-05
05708296394586BeltoneGn Hearing A/SKLW2026-10-05
05708296394593BeltoneGn Hearing A/SKLW2026-10-05
05708296394654BeltoneGn Hearing A/SKLW2026-10-05
05708296394661BeltoneGn Hearing A/SKLW2026-10-05
05708296394678BeltoneGn Hearing A/SKLW2026-10-05
05708296397877BeltoneGn Hearing A/SKLW2026-10-05
05708296397884BeltoneGn Hearing A/SKLW2026-10-05
05708296397945BeltoneGn Hearing A/SKLW2026-10-05
05708296397952BeltoneGn Hearing A/SKLW2026-10-05
05708296397969BeltoneGn Hearing A/SKLW2026-10-05
05708296429455BeltoneGn Hearing A/SKLW2026-10-05
05708296429462BeltoneGn Hearing A/SKLW2026-10-05
05708296429523BeltoneGn Hearing A/SKLW2026-10-05
05708296429530BeltoneGn Hearing A/SKLW2026-10-05
05708296429547BeltoneGn Hearing A/SKLW2026-10-05