FDA.reportPublic FDA data

OXILINE

Primary DI
06971094538097
Brand
OXILINE
Company
Huizhou Jinghao Medical Technology Co., Ltd
Model
JH-DW3F
Published
2025-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QUHSelf-Fitting Air-Conduction Hearing Aid, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUHSelf-Fitting Air-Conduction Hearing Aid, Over The CounterEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221052000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221052000Self-Fitting hearing aidsHuizhou Jinghao Medical Technology Co., Ltd.2023-09-25QUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971094538094PackageGS150In Commercial Distribution
06971094538097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697109453809416971094538094
06971094538097069710945380976971094538097

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, behind-the-earA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum through an earmould that fits inside the outer ear or a tube in the ear canal. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Regulatory Flags#

DUNS number
547508199
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971094538721KLARIQJH-A2602026-05-26
06971094538738KLARIQJH-A26A2026-05-26
06971094538707XQYMJH-DW2ET2026-05-08
06971094538677AntOkayJH-DW4E2026-05-01
06971094538691OricleJH-A1702026-04-30
06971094538622Savvy SmartJH-A2602026-03-25
06971094538639Spade & CoJH-A19A2026-03-24
06971094538615GIATATHAJH-A19A2026-03-20
06971094538592LITOULFJH-A2602026-03-18
06971094538585Bachgold JH-A2602026-02-05
06971094538561HARMONIXJH-A32E2026-01-20
06971094538530LITOULFJH-A2602025-12-19
06971094539483JINGHAOJH-A26A2025-12-08
06971094538509NacenacyJH-DW2ET2025-12-01
06971094538516Nacenacy VillearJH-DW2ET2025-12-01
16971094538506NacenacyJH-DW2ET2025-12-01
16971094538513Nacenacy VillearJH-DW2ET2025-12-01
06971094538493Sharper ImageJH-A26D2025-11-21
06971094539469JINGHAOJH-DW4E2025-10-08
06971094538486H-earrings JH-D13B2025-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810153660323Lexie B3 Hearing AidsHEARX GROUP (PTY) LTDQUH2026-05-07
00850010429786Eargo 8Eargo, Inc.QUH2026-04-20
00850010429847Eargo SEEargo, Inc.QUH2026-04-20
06971094538561HARMONIXHuizhou Jinghao Medical Technology Co., LtdQUH2026-01-20
00850010429779Eargo SEEargo, Inc.QUH2025-10-22
00810153660811Lexie HearingHEARX GROUP (PTY) LTDQUH2025-07-31
00850010429304Eargo 8Eargo, Inc.QUH2025-05-13
00850010429328Eargo 8Eargo, Inc.QUH2025-05-13
00850010429540Eargo 8Eargo, Inc.QUH2025-05-13
00850010429687Eargo 8Eargo, Inc.QUH2025-05-13
00850010429694Eargo 8Eargo, Inc.QUH2025-05-13
00850010429700Eargo 8Eargo, Inc.QUH2025-05-13
00850010429717Eargo 8Eargo, Inc.QUH2025-05-13
00850010429724Eargo 8Eargo, Inc.QUH2025-05-13
00850010429793Eargo 8Eargo, Inc.QUH2025-05-13
00850010429809Eargo 8Eargo, Inc.QUH2025-05-13
00046838505065JVCNovidan, Inc.QUH2025-05-07
00850010429816Eargo SEEargo, Inc.QUH2025-04-07
00850010429731Eargo SEEargo, Inc.QUH2025-04-03
00850010429748Eargo SEEargo, Inc.QUH2025-04-03
00850010429755Eargo SEEargo, Inc.QUH2025-04-03
00850010429762Eargo SEEargo, Inc.QUH2025-04-03
16971094538094OXILINEHuizhou Jinghao Medical Technology Co., LtdQUH2025-03-24
06971094537991AudialnetHuizhou Jinghao Medical Technology Co., LtdQUH2025-02-25
16971094537998AudialnetHuizhou Jinghao Medical Technology Co., LtdQUH2025-02-25
00860010331033CeretoneAudicon CorporationQUH2024-09-04
10860010331030CeretoneAudicon CorporationQUH2024-09-04
06971094537793RETEKESSHuizhou Jinghao Medical Technology Co., LtdQUH2024-09-02
16971094537790RETEKESSHuizhou Jinghao Medical Technology Co., LtdQUH2024-09-02
06971094537748AudialnetHuizhou Jinghao Medical Technology Co., LtdQUH2024-08-14