FDA.reportPublic FDA data

Desyncra For Tinnitus Therapy System

Primary DI
EDYGTI1002EU01
Brand
Desyncra For Tinnitus Therapy System
Company
Desyncra Operating GmbH
Model
Size M
Catalog number
TI10.02EU_01
Published
2018-03-02
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
K151558000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151558000Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro SystemNeurotherapies Reset GmbH2016-01-20KLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDYGTI1002EU01PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tinnitus masking application softwareAn individual software application program or group of programs, routines or algorithms designed for use in, or together with, other devices such as a computer, a digital hearing aid, or formated into a compact disc read-only memory (CD-ROM) or an MP3 format to enable it to provide generated noise of sufficient intensity and bandwidth to mask (make less noticeable and provide temporary relief from) tinnitus (a ringing sound in the ear or internal head noises). The basic set of applications programs and routines can be upgraded to add new system capabilities. Application program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
313625455
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EDYGTI1001EU01Desyncra For Tinnitus Therapy SystemSize STI10.01EU_012018-03-02
EDYGTI1003EU01Desyncra For Tinnitus Therapy SystemSize LTI10.03EU_012018-03-02
EDYGTI1004EU01Desyncra For Tinnitus Therapy SystemSize XLTI10.04EU_012018-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840388220580Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220597Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220757Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220764Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220771Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220788Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220795Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220801Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220818Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220825Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220863Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220917Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220955Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220993Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221006Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221013Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221020Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221037Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221044Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221051Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221068Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221075Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221136Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221181Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221228Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221266Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221280Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221297Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221303Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221327Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04