FDA.reportPublic FDA data

ELEHEAR Alpha

Primary DI
69743465514172
Brand
ELEHEAR Alpha
Company
Elevoc Technology Co.,Ltd.
Model
RIC 02
Published
2023-09-30
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
QUFHearing Aid, Air-Conduction, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUFHearing Aid, Air-Conduction, Over The CounterEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
69743465502193PackageGS120In Commercial Distribution
69743465514172PrimaryGS10
06974346551417Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
6974346550219369743465502193
6974346551417269743465514172
06974346551417069743465514176974346551417

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, wearable caseA 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 on the body (e.g., in a pocket or on a belt). 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 connected to the case by a cord. Because it's relatively large size permits high amplification, this device has been used for profound hearing loss; it has largely been replaced with behind-the-ear (BTE) devices.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius45 Degrees Celsius

Regulatory Flags#

DUNS number
544581147
Device count
1000
DM exempt
true
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
69743465514004ELEHEAR Alpha ProRIC 012023-09-30
06974346551417ELEHEAR AlphaRIC 022023-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971094538721KLARIQHuizhou Jinghao Medical Technology Co., LtdQUF2026-05-26
06971094538738KLARIQHuizhou Jinghao Medical Technology Co., LtdQUF2026-05-26
06971094538707XQYMHuizhou Jinghao Medical Technology Co., LtdQUF2026-05-08
06971094538691OricleHuizhou Jinghao Medical Technology Co., LtdQUF2026-04-30
06973967150276WuveeXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150283NebrooXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150313VienatoneXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150320VienatoneXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150368NebrooXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150573VienatoneXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06971094538622Savvy SmartHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-25
06971094538639Spade & CoHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-24
06971094538615GIATATHAHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-20
06971094538592LITOULFHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-18
06950715563090CofoeCofoe Medical Technology Co.,LtdQUF2026-02-24
06971094538585Bachgold Huizhou Jinghao Medical Technology Co., LtdQUF2026-02-05
06979053570034UltrotingShenzhen Magnet Technology Co., LtdQUF2026-01-21
06979053570041UltrotingShenzhen Magnet Technology Co., LtdQUF2026-01-21
06971094538530LITOULFHuizhou Jinghao Medical Technology Co., LtdQUF2025-12-19
06978898058011Viva HearShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058028Viva HearShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058035Viva HearShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058042Xpect VisionShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058059Xpect VisionShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058066Xpect VisionShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06975958550010MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550119MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550225MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550232MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550249MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09