FDA.reportPublic FDA data

ELITE BRITE

Primary DI
06973712280104
Brand
ELITE BRITE
Company
Hengshui Tianjian Medical Supplies CO.,LTD
Model
XL
Published
2024-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
06973712280104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973712280104069737122801046973712280104

GMDN Terms#

Term, Definition table
TermDefinition
Adhesive lumbar supportA device intended to be externally adhered to the lower back for support to assist with posture improvement and/or to help relieve low back pain. It consists of a preformed shape of orthopaedic adhesive tape with a stiff internal strut typically of made of polymer materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529951803
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973712280395HSYS2026-03-27
06973712280401HSYM2026-03-27
06973712280418HSYL2026-03-27
06973712280425HSYXL2026-03-27
06973712280388Elite Briteuniversal 2024-11-29
06973712280111ELITE BRITEuniversal 2024-06-03
06973712280128ELITE BRITEuniversal 2024-06-03
06973712280135ELITE BRITEAdult universal 2024-06-03
06973712280142ELITE BRITEChild universal 2024-06-03
06973712280159ELITE BRITES Left2024-06-03
06973712280166ELITE BRITEM Left2024-06-03
06973712280173ELITE BRITEL Left2024-06-03
06973712280180ELITE BRITEXL Left2024-06-03
06973712280197ELITE BRITES Right2024-06-03
06973712280203ELITE BRITEM Right2024-06-03
06973712280210ELITE BRITEL Right2024-06-03
06973712280227ELITE BRITEXL Right2024-06-03
06973712280234ELITE BRITES Left2024-06-03
06973712280241ELITE BRITEM Left2024-06-03
06973712280258ELITE BRITEL Left2024-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06979144490371Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490388Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490395Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490401Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490418Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490425Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18