FDA.reportPublic FDA data

IFLYTEK

Primary DI
06945936705619
Brand
IFLYTEK
Company
Xiamen New Sound Technology Co., Ltd.
Model
VAN 203 Pro
Published
2025-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OSMHearing Aid, Air-Conduction With Wireless Technology, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945936705619PrimaryGS10
16945936705616Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945936705619069459367056196945936705619
1694593670561616945936705616

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, behind-the-earA 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 microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). 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 through an earmould that fits inside the outer ear or a tube in the ear canal. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Regulatory Flags#

DUNS number
528181200
Device count
2
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
06945936705626RETEKESSTE1032025-12-16
16945936705623RETEKESSTE1032025-12-16
06945936705602IFLYTEKVAN 610 Pro2025-12-02
16945936705609IFLYTEKVAN 610 Pro2025-12-02
16945936705616IFLYTEKVAN 203 Pro2025-12-02
06945936705299METIKOelclear 91062025-09-02
16945936705296METIKOelclear 91062025-09-02
06945936704889AHA TechnologiesPureEQ2025-02-12
16945936704886AHA TechnologiesPureEQ2025-02-12
06945936704834PowerLixPoco M4012024-12-11
16945936704831PowerLixPoco M4012024-12-11
06945936704742NewsoundPrimo RA2024-11-28
06945936704759NewsoundRealtone2024-11-28
06945936704766Newsound Puretone2024-11-28
06945936704773NewsoundSupertone2024-11-28
06945936704780NewsoundWing2024-11-28
06945936704797NewsoundClass D2024-11-28
06945936704063NanoFirst Ear Plus ITE2024-05-21
06945936704070NanoFirst Ear Plus BTE2024-05-21
06945936704087NanoFirst Ear Pro BTE2024-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613275596814PhonakSonova AGOSM2018-02-28
07613275596845PhonakSonova AGOSM2018-02-28
07613275596869PhonakSonova AGOSM2018-02-28
07613275596883PhonakSonova AGOSM2018-02-28
07613275596944PhonakSonova AGOSM2018-02-28
07613275596951PhonakSonova AGOSM2018-02-28
07613275596968PhonakSonova AGOSM2018-02-28
07613275596982PhonakSonova AGOSM2018-02-28
07613275596999PhonakSonova AGOSM2018-02-28
07613275597002PhonakSonova AGOSM2018-02-28
07613275597019PhonakSonova AGOSM2018-02-28
07613275597033PhonakSonova AGOSM2018-02-28
07613275601327PhonakSonova AGOSM2018-02-28
07613275601402PhonakSonova AGOSM2018-02-28
07613275601426PhonakSonova AGOSM2018-02-28
07613275601501PhonakSonova AGOSM2018-02-28
07613275601518PhonakSonova AGOSM2018-02-28
07613275601556PhonakSonova AGOSM2018-02-28
07613275601594PhonakSonova AGOSM2018-02-28
07613275601600PhonakSonova AGOSM2018-02-28
07613275601655PhonakSonova AGOSM2018-02-28
07613275601662PhonakSonova AGOSM2018-02-28
07613275601686PhonakSonova AGOSM2018-02-28
07613275601693PhonakSonova AGOSM2018-02-28
07613275602935PhonakSonova AGOSM2018-02-28
07613275602959PhonakSonova AGOSM2018-02-28
07613275603000PhonakSonova AGOSM2018-02-28
07613275603017PhonakSonova AGOSM2018-02-28
07613275603048PhonakSonova AGOSM2018-02-28
07613275603062PhonakSonova AGOSM2018-02-28