FDA.reportPublic FDA data

TIANLE

Primary DI
06937572805037
Brand
TIANLE
Company
Zhongshan Tianle Hearing Technology Co., Ltd.
Model
TL-516M
Device description
In The Canal Hearing 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
06937572805037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06937572805037069375728050376937572805037

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, canalA 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 miniature microphone, amplifier, and speaker (receiver) in a case that fits the ear canal [in-the-canal (ITC)] or in a case nearly hidden in the ear canal [completely-in-the-canal (CIC)]. 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. It is used for mild to moderately-severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

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