FDA.reportPublic FDA data

Aroma Sense

Primary DI
08809186432504
Brand
Aroma Sense
Company
Korea New Tech Co., Ltd.
Model
AS-9000R
Device description
AROMA VITAMIN C SHOWER HEAD
Published
2022-01-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
IQEOrthosis, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQEOrthosis, LumbarPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809186432504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809186432504088091864325048809186432504

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar spine orthosisAn externally applied orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688550503
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809186430135Aroma SenseAROFIX-012022-01-14
08809186430142Aroma SenseAROFIX-022022-01-14
08809186436007Aroma SenseAS-90002022-01-14
08809186437011Aroma SenseAS-PRESTIGE(NORMAL)2022-01-14
08809186437028Aroma SenseAS-701ST2022-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810179882211CopperFitIdeavillage Products CorpIQE2026-10-01
00810179882228CopperFitIdeavillage Products CorpIQE2026-10-01
00810179882235CopperFitIdeavillage Products CorpIQE2026-10-01
00810179882242CopperFitIdeavillage Products CorpIQE2026-10-01
00810179882259CopperFitIdeavillage Products CorpIQE2026-10-01
00810179882402CopperFitIdeavillage Products CorpIQE2026-10-01
04068903520939MEDIMEDI MANUFACTURING, INC.IQE2026-08-21
04068903520946MEDIMEDI MANUFACTURING, INC.IQE2026-08-21
04068903520953MEDIMEDI MANUFACTURING, INC.IQE2026-08-21
04068903520960MEDIMEDI MANUFACTURING, INC.IQE2026-08-21
04068903520977MEDIMEDI MANUFACTURING, INC.IQE2026-08-21
06979144490449Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-20
06979144490456Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-20
06979144490463Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-20
06979144490470Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-20
06979144490487Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-20
00810178889648CoreTechVIVE HEALTH LLCIQE2026-08-19
06979144490241Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490258Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490265Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490272Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490289Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490296Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490302Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490319Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490326Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490333Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490340Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490357Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490364Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18