FDA.reportPublic FDA data

TIANLE

Primary DI
06937572805242
Brand
TIANLE
Company
Zhongshan Tianle Hearing Technology Co., Ltd.
Model
TL-625M
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
QSMSystem, Surgical, Computer Controlled Instrument, Remanufactured

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSMSystem, Surgical, Computer Controlled Instrument, RemanufacturedGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06937572805242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06937572805242069375728052426937572805242

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
06937572803804TIANLETL-628G2025-04-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06937572804399TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804405TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804412TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804429TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804436TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804443TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804450TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804467TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804474TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804481TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804498TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804504TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804511TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804528TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804535TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804542TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804559TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804566TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804573TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804580TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804597TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804603TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804610TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804627TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804634TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804641TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804658TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804665TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804672TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804689TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02