FDA.report

TIANLE

Primary DI
06937572803897
Brand
TIANLE
Company
Zhongshan Tianle Hearing Technology Co., Ltd.
Model
TL-639G
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

Related Records

Product Codes

CodeName
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Product Code Classifications

CodeDeviceSpecialtyClass
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The CounterEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06937572803897PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06937572803897069375728038976937572803897

GMDN Terms

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

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 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
06937572803903TIANLETL-650G2025-04-02
06937572803910TIANLETL-651G2025-04-02
06937572803927TIANLETL-652G2025-04-02
06937572803934TIANLETF-950G2025-04-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850080488249flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-03-06
16974308960209Retone, NebrooXiamen Retone Hearing Technology Co., LtdQUG2026-02-05
00850080488140flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-01-16
05714880290356hear.comWs Audiology Usa, Inc.QUG2026-01-12
16974308960193Retone Xiamen Retone Hearing Technology Co., LtdQUG2026-01-08
06977352080438ELEHEARELEHEAR Inc.QUG2025-12-31
06943786079911AUSTARAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.QUG2025-12-03
05708296386239GN HearingGn Hearing A/SQUG2025-09-21
05708296386246GN HearingGn Hearing A/SQUG2025-09-21
05708296391240GN HearingGn Hearing A/SQUG2025-09-21
05708296386253GN HearingGn Hearing A/SQUG2025-09-19
05708296386260GN HearingGn Hearing A/SQUG2025-09-19
05708296386277GN HearingGn Hearing A/SQUG2025-09-19
05708296386284GN HearingGn Hearing A/SQUG2025-09-19
05708296386291GN HearingGn Hearing A/SQUG2025-09-19
05708296386307GN HearingGn Hearing A/SQUG2025-09-19
05708296386314GN HearingGn Hearing A/SQUG2025-09-19
05708296386321GN HearingGn Hearing A/SQUG2025-09-19
05708296386338GN HearingGn Hearing A/SQUG2025-09-19
05708296386345GN HearingGn Hearing A/SQUG2025-09-19
05708296386352GN HearingGn Hearing A/SQUG2025-09-19
05708296386369GN HearingGn Hearing A/SQUG2025-09-19
05708296386376GN HearingGn Hearing A/SQUG2025-09-19
05708296391189GN HearingGn Hearing A/SQUG2025-09-19
05708296391196GN HearingGn Hearing A/SQUG2025-09-19
05708296391202GN HearingGn Hearing A/SQUG2025-09-19
05708296391219GN HearingGn Hearing A/SQUG2025-09-19
05708296391226GN HearingGn Hearing A/SQUG2025-09-19
05708296391233GN HearingGn Hearing A/SQUG2025-09-19
05708296391257GN HearingGn Hearing A/SQUG2025-09-19