FDA.reportPublic FDA data

Levo

Primary DI
G172604520
Brand
Levo
Company
Levo Medical Corporation
Model
Patient
Catalog number
60452
Published
2022-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K140845000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140845000LEVO TINNITUS MASKING SOFTWARE DEVICEOtoharmonics Corp2014-07-18KLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B400215930PreviousHIBCC0
G172604520PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
1-866-306-1387info@levomedical.com

Regulatory Flags#

DUNS number
204319466
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G172616890LevoManager616892022-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
05714880219432Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219449Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219456Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219463Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219470Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219869Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219876Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219883Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219890Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219906Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219913Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219944Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219951Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
07613275596821PhonakSonova AGKLW2018-02-28
07613275596838PhonakSonova AGKLW2018-02-28