FDA.reportPublic FDA data

Cofoe

Primary DI
06950715501627
Brand
Cofoe
Company
Cofoe Medical Technology Co.,Ltd
Model
KFYG007
Device description
Lumbar Support belt
Published
2024-06-25
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
06950715501627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06950715501627069507155016276950715501627

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar spine orthosisA prefabricated (non-customized) externally applied and wearable 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
544425204
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06950715563090CofoeZBC242026-02-24
06950715500002COFOEZA-012022-01-10
06950715500019COFOEDM3792022-01-10
06950715500026COFOECC3302022-01-10
06950715500033COFOERC3302022-01-10
06950715500040COFOESPTT3302022-01-10
06950715500057COFOEPTT3302022-01-10
06950715500064COFOESPTT9202022-01-10
06950715500071COFOEPTT9202022-01-10
06950715500088COFOECC9202022-01-10
06950715500095COFOEICS920-B2022-01-10
06950715500101COFOEF3002022-01-10
06950715500118COFOEICS300-B2022-01-10
06950715500125COFOECC102022-01-10
06950715500132COFOECN9202022-01-10
06950715500149COFOEICS3302022-01-10
06950715501665CofoeKF-GDD-F012024-07-04
06950715501672CofoeKF-GDD-F022024-07-04
06950715501689CofoeKF-GDD-F032024-07-04
06950715501696CofoeKF-GDD-F042024-07-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178882533CoreTechVIVE HEALTH LLCIQE2026-02-09
00810178884520CoreTechVIVE HEALTH LLCIQE2025-10-30
00810179882044CopperFitIdeavillage Products CorpIQE2025-10-10
00810179882099CopperFitIdeavillage Products CorpIQE2025-10-10
00810179882105CopperFitIdeavillage Products CorpIQE2025-10-10
00810113682686Tailback 27Manamed, Inc.IQE2025-09-19
00810113682693Tailback2-42Manamed, Inc.IQE2025-09-19
00810113682723Tailback2-64Manamed, Inc.IQE2025-09-19
00860014460807Boston Body Jacket, Single OpeningBoston Brace International, Inc.IQE2025-08-05
00860014460814Boston Body Jacket, Bivalve OpeningBoston Brace International, Inc.IQE2025-08-05
00860014460821Boston Overlap Brace (BOB)Boston Brace International, Inc.IQE2025-08-05
00636257203651MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203668MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203675MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203682MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203699MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203705MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203712MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203729MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203736MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203743MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203750MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203767MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204801MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204818MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204825MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204832MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204849MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204856MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204863MEDIMEDI MANUFACTURING, INC.IQE2025-06-24