FDA.reportPublic FDA data

flysound

Primary DI
00850080488140
Brand
flysound
Company
Shenzhen Flysounds Medical Technology Co.,Ltd.
Model
H6
Published
2026-01-16
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
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The CounterEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850080488140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850080488140008500804881408500804881400850080488140

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
978407839
Device count
1
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
00850080488577flysoundB012026-08-25
00850080488584flysoundB01 Pro2026-08-25
00850080488249flysoundB022026-03-06
00850080488072flysoundT552025-11-14
06978516630025flysoundH82025-08-15
06978516630032flysoundH92025-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971094539506JinghaoHuizhou Jinghao Medical Technology Co., LtdQUG2026-11-05
06974608620042TUITUIShenzhen Eartech Co., Ltd.QUG2026-11-02
06974608620066TUITUIShenzhen Eartech Co., Ltd.QUG2026-11-02
06974608620073TUITUIShenzhen Eartech Co., Ltd.QUG2026-11-02
06974608620097TUITUIShenzhen Eartech Co., Ltd.QUG2026-11-02
06974608620103TUITUIShenzhen Eartech Co., Ltd.QUG2026-11-02
06974608620158TUITUIShenzhen Eartech Co., Ltd.QUG2026-11-02
06974608620202TUITUIShenzhen Eartech Co., Ltd.QUG2026-11-02
06974608620219TUITUIShenzhen Eartech Co., Ltd.QUG2026-11-02
06974608620240TUITUIShenzhen Eartech Co., Ltd.QUG2026-11-02
00777799619927nuance audioLUXOTTICA GROUP SPAQUG2026-10-27
08056262930700nuance audioLUXOTTICA GROUP SPAQUG2026-10-27
06977171530190TECHMITechmi (HongKong) Co., LimitedQUG2026-09-30
06977171530206TECHMITechmi (HongKong) Co., LimitedQUG2026-09-30
06977171530220TECHMITechmi (HongKong) Co., LimitedQUG2026-09-30
06977189201167NAYeasound (Xiamen) Hearing Technology Co., LtdQUG2026-09-30
06979809410003Hearing AidsShenzhen Anker Medical Devices Co., Ltd.QUG2026-09-22
06943786094839AUDIENAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.QUG2026-09-20
06977352080612ELEHEARELEHEAR Inc.QUG2026-09-05
06977352080629ELEHEARELEHEAR Inc.QUG2026-09-05
06977352080681ELEHEARELEHEAR Inc.QUG2026-09-05
06977352080698ELEHEARELEHEAR Inc.QUG2026-09-05
06974608620523PHONELUMShenzhen Eartech Co., Ltd.QUG2026-08-27
00850080488577flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-08-25
00850080488584flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-08-25
00850065321967CeretoneAudicon CorporationQUG2026-08-14
06943786094846AUSTARAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.QUG2026-08-14
08056262819890nuance audioLUXOTTICA GROUP SPAQUG2026-07-31
08056262856789nuance audioLUXOTTICA GROUP SPAQUG2026-07-31
06980305290013CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25