FDA.reportPublic FDA data

KYTO

Primary DI
06978096608896
Brand
KYTO
Company
KYTO FITNESS TECHNOLOGY CO., LIMITED
Model
KYTO2880
Published
2025-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The CounterEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06978096608896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06978096608896069780966088966978096608896

GMDN Terms#

Term, Definition table
TermDefinition
Glomerular basement membrane antibody (Goodpasture antibody) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antibodies to glomerular basement membrane (anti-GBM) or Goodpasture antibodies in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
526968903
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06978096608803KYTOKYTO28802025-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973967150658EaraXiamen Vienatone Medical Technology Co., Ltd.QUG2026-05-19
06971094538677AntOkayHuizhou Jinghao Medical Technology Co., LtdQUG2026-05-01
06973967150351Audien HearingXiamen Vienatone Medical Technology Co., Ltd.QUG2026-04-28
00860015094803LegatoLEGATO AUDIO, INC.QUG2026-03-25
00860015094810LegatoLEGATO AUDIO, INC.QUG2026-03-25
00860015094827LegatoLEGATO AUDIO, INC.QUG2026-03-25
00860015094834LegatoLEGATO AUDIO, INC.QUG2026-03-25
00850080488249flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-03-06
16974308960209Retone, NebrooXiamen Retone Hearing Technology Co., LtdQUG2026-02-05
00850080488140flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-01-16
05714880290325hear.comWs Audiology Usa, Inc.QUG2026-01-12
05714880290332hear.comWs Audiology Usa, Inc.QUG2026-01-12
05714880290349hear.comWs Audiology Usa, Inc.QUG2026-01-12
05714880290356hear.comWs Audiology Usa, Inc.QUG2026-01-12
16974308960193Retone Xiamen Retone Hearing Technology Co., LtdQUG2026-01-08
06977352080438ELEHEARELEHEAR Inc.QUG2025-12-31
06943786079911AUSTARAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.QUG2025-12-03
06975958551277MirasingXiamen Mirasing Technology Co.,Ltd.QUG2025-11-03
00810153660828Lexie H1 OTC Hearing BudsHEARX GROUP (PTY) LTDQUG2025-10-01
06971094538486H-earrings Huizhou Jinghao Medical Technology Co., LtdQUG2025-10-01
05708296386239GN HearingGn Hearing A/SQUG2025-09-21
05708296386246GN HearingGn Hearing A/SQUG2025-09-21
05708296391240GN HearingGn Hearing A/SQUG2025-09-21
05708296386253GN HearingGn Hearing A/SQUG2025-09-19
05708296386260GN HearingGn Hearing A/SQUG2025-09-19
05708296386277GN HearingGn Hearing A/SQUG2025-09-19
05708296386284GN HearingGn Hearing A/SQUG2025-09-19
05708296386291GN HearingGn Hearing A/SQUG2025-09-19
05708296386307GN HearingGn Hearing A/SQUG2025-09-19
05708296386314GN HearingGn Hearing A/SQUG2025-09-19