FDA.reportPublic FDA data

Copperfit

Primary DI
00810179882273
Brand
Copperfit
Company
Ideavillage Products Corp
Model
CFIADARMD
Device description
CopperFit Arch Orthotic Insole MD
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
KYSInsoles, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYSInsoles, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810179882273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810179882273008101798822738101798822730810179882273

GMDN Terms#

Term, Definition table
TermDefinition
Orthotic insole, prefabricated, antimicrobialA prefabricated orthopaedic shoe insert typically available for use by a layperson intended to provide supplemental support for the arch and/or heel of the foot, whilst inhibiting microbes such as viruses, bacteria and fungi. It is typically made of fabric and/or synthetic polymer materials (e.g., wool, viscose, silicone gel, foam) impregnated with an antimicrobial substance, which is designed to resist extreme load and may provide thermal insulation. 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
false
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
00810179882235CopperFitCFMAXBACKLXL2026-10-01
00810179882242CopperFitCFMAXBACK2X3X2026-10-01
00810179882259CopperFitCFDABACK1SZ2026-10-01
00810179882266CopperfitCFIADARSM2026-10-01
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
00810179882266CopperfitIdeavillage Products CorpKYS2026-10-01
00810179882280CopperfitIdeavillage Products CorpKYS2026-10-01
00810179882297CopperfitIdeavillage Products CorpKYS2026-10-01
04744946011787ESTCARBON Erismet OUKYS2024-10-29
04744946011794ESTCARBON Erismet OUKYS2024-10-29
04744946011800ESTCARBON Erismet OUKYS2024-10-29
04744946011817ESTCARBON Erismet OUKYS2024-10-29
04744946011824ESTCARBON Erismet OUKYS2024-10-29
04744946011831ESTCARBON Erismet OUKYS2024-10-29
04744946011848ESTCARBON Erismet OUKYS2024-10-29
04744946011923ESTCARBON Erismet OUKYS2024-10-29
04744946011770ESTCARBON Erismet OUKYS2024-10-28
04744946011749ESTCARBON Erismet OUKYS2024-09-20
04744946011756ESTCARBON Erismet OUKYS2024-09-20
04744946011763ESTCARBON Erismet OUKYS2024-09-20
04744946010094ESTCARBON Erismet OUKYS2024-09-09
04744946010100ESTCARBON Erismet OUKYS2024-09-09
04744946010209ESTCARBON Erismet OUKYS2024-09-09
04744946010308ESTCARBON Erismet OUKYS2024-09-09
04744946011886ESTCARBON Erismet OUKYS2024-09-09
04744946011893ESTCARBON Erismet OUKYS2024-09-09
04744946011909ESTCARBON Erismet OUKYS2024-09-09
04744946011930ESTCARBON Erismet OUKYS2024-09-09
04744946011947ESTCARBON Erismet OUKYS2024-09-09
04744946011954ESTCARBON Erismet OUKYS2024-09-09
04744946011961ESTCARBON Erismet OUKYS2024-09-09
04744946011978ESTCARBON Erismet OUKYS2024-09-09
04744946012111ESTCARBON Erismet OUKYS2024-09-09
04744946012128ESTCARBON Erismet OUKYS2024-09-09
04744946012135ESTCARBON Erismet OUKYS2024-09-09