FDA.reportPublic FDA data

CopperFit

Primary DI
00810179882235
Brand
CopperFit
Company
Ideavillage Products Corp
Model
CFMAXBACKLXL
Device description
Copper Fit Max Back Posture Belt LXL
Published
2026-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00810179882235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810179882235008101798822358101798822350810179882235

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.

Regulatory Flags#

DUNS number
124259503
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810179882211CopperFitCFPROAIRBKSM, CFPROAIRBKSM1002026-10-01
00810179882228CopperFitCFMAXBACKSM2026-10-01
00810179882242CopperFitCFMAXBACK2X3X2026-10-01
00810179882259CopperFitCFDABACK1SZ2026-10-01
00810179882266CopperfitCFIADARSM2026-10-01
00810179882273CopperfitCFIADARMD2026-10-01
00810179882280CopperfitCFIADARLG2026-10-01
00810179882297CopperfitCFIADARXL2026-10-01
00810179882327CopperfitCFHYDSKWHSMW2026-10-01
00810179882334CopperfitCFHYDSKWHLXW2026-10-01
00810179882341CopperfitCFDACPSKBLSM2026-10-01
00810179882358CopperfitCFDACPSKBLLX2026-10-01
00810179882365CopperFitCFDAGLSM, CFMOBGLSM2026-10-01
00810179882372CopperFitCFDAGLLXL, CFMOBGLLXL2026-10-01
00810179882389CopperfitCFPROAIRKNSM2026-10-01
00810179882396CopperfitCFPROAIRKNLXL2026-10-01
00810179882402CopperFitCFPROAIRBKLXL, CFPROAIRLXL1002026-10-01
00810179882419CopperfitCFIPKNSM242026-10-01
00810179882426CopperfitCFIPKNLXL242026-10-01
00810179882488CopperfitCFRR360SM2026-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810179882211CopperFitIdeavillage Products CorpIQE2026-10-01
00810179882228CopperFitIdeavillage 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
06979144490371Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18