FDA.reportPublic FDA data

ELITE BRITE

Primary DI
06973712280067
Brand
ELITE BRITE
Company
Hengshui Tianjian Medical Supplies CO.,LTD
Model
universal
Published
2024-05-24
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
06973712280067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973712280067069737122800676973712280067

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
06973712280104ELITE BRITEXL2024-06-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843776103168Neotech CareNEOTECH CARE INC.IQE2026-07-20
00843776103175Neotech CareNEOTECH CARE INC.IQE2026-07-20
00843776103182Neotech CareNEOTECH CARE INC.IQE2026-07-20
00843776103199Neotech CareNEOTECH CARE INC.IQE2026-07-20
00843776103205Neotech CareNEOTECH CARE INC.IQE2026-07-20
00843776103212Neotech CareNEOTECH CARE INC.IQE2026-07-20
00843776103229Neotech CareNEOTECH CARE INC.IQE2026-07-20
00843776103236Neotech CareNEOTECH CARE INC.IQE2026-07-20
00843776103243Neotech CareNEOTECH CARE INC.IQE2026-07-20
00843776103250Neotech CareNEOTECH CARE INC.IQE2026-07-20
00843776106381Neotech CareNEOTECH CARE INC.IQE2026-07-20
00843776106398Neotech CareNEOTECH CARE INC.IQE2026-07-20
00843776106404Neotech CareNEOTECH CARE INC.IQE2026-07-20
00843776106428Neotech CareNEOTECH CARE INC.IQE2026-07-20
00843776106435Neotech CareNEOTECH CARE INC.IQE2026-07-20
00843776106442Neotech CareNEOTECH CARE INC.IQE2026-07-20
00843776106459Neotech CareNEOTECH CARE INC.IQE2026-07-20
00843776106466Neotech CareNEOTECH CARE INC.IQE2026-07-20
00843776106367Neotech CareNEOTECH CARE INC.IQE2026-07-17
00843776106374Neotech CareNEOTECH CARE INC.IQE2026-07-17
00843776100013Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100020Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100037Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100044Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100051Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100099Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102499Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102505Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102512Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102529Neotech CareNEOTECH CARE INC.IQE2026-07-14