FDA.reportPublic FDA data

TIANLE

Primary DI
06937572805266
Brand
TIANLE
Company
Zhongshan Tianle Hearing Technology Co., Ltd.
Model
TL-628M
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
Rx
false
OTC
true
Sterile
false
Single use
false

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
06937572805266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06937572805266069375728052666937572805266

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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