FDA.reportPublic FDA data

TIANLE

Primary DI
06937572803804
Brand
TIANLE
Company
Zhongshan Tianle Hearing Technology Co., Ltd.
Model
TL-628G
Device description
Neckband Heairng Aid
Published
2025-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
06937572803804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06937572803804069375728038046937572803804

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid neck induction loop, wireless inputA portable, battery-powered device worn around the neck intended to receive sound from an audio source [e.g., mobile (cellular) telephone] wirelessly (e.g., via Bluetooth) and transfer it via an audio frequency magnetic field to a hearing aid with an induction coil (i.e., bypassing the hearing aids microphone) when it is switched to the "T" or `?MT?? position, in order for the hearing aid user to hear (e.g., telephone conversation, music) more clearly. It typically consists of small active amplifier with a wire loop worn around the neck. It may also include a microphone for hands-free telephone conversation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
546790267
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06937572802470TIANLETF-950F2025-04-02
06937572802487TIANLETF-951F2025-04-02
06937572803750TIANLETL-621G2025-04-02
06937572803767TIANLETL-622G2025-04-02
06937572803774TIANLETL-623G2025-04-02
06937572803781TIANLETL-625G2025-04-02
06937572803798TIANLETL-626G2025-04-02
06937572803811TIANLETL-629G2025-04-02
06937572803828TIANLETL-630G2025-04-02
06937572803835TIANLETL-631G2025-04-02
06937572803842TIANLETL-632G2025-04-02
06937572803859TIANLETL-633G2025-04-02
06937572803866TIANLETL-635G2025-04-02
06937572803873TIANLETL-636G2025-04-02
06937572803880TIANLETL-638G2025-04-02
06937572803897TIANLETL-639G2025-04-02
06937572803903TIANLETL-650G2025-04-02
06937572803910TIANLETL-651G2025-04-02
06937572803927TIANLETL-652G2025-04-02
06937572803934TIANLETF-950G2025-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06980134820016n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820023n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820030n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820047n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820054n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820061n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820078n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820085n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820092n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820108n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820115n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820122n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820139n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820146n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820153n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820160n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820177n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820184n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820191n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820207n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820214n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820221n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820238n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820245n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820252n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820269n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820276n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820283n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06973967150658EaraXiamen Vienatone Medical Technology Co., Ltd.QUG2026-05-19
06971094538677AntOkayHuizhou Jinghao Medical Technology Co., LtdQUG2026-05-01