FDA.reportPublic FDA data

CopperFit

Primary DI
00810179882037
Brand
CopperFit
Company
Ideavillage Products Corp
Model
CFMOBAKLXL12
Device description
CopperFit Dual Action Ankle Sleeve L/XL
Published
2025-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ITWJoint, Ankle, External Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITWJoint, Ankle, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810179882037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810179882037008101798820378101798820370810179882037

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure tubular garmentA device in the form of a tube intended to tightly fit over and apply compression/pressure (i.e., graduated or even-force) to a part of a limb, typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)], to control scarring, and/or to manage lymphoedema; it is neither a strip/roll binder, glove, sock/stocking, nor tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex); it does not include antimicrobial features. This is a reusable device.

Regulatory Flags#

DUNS number
124259503
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810179881498CopperfitCFDAELGELSM2026-06-01
00810179882457CopperfitCFDAELGELLXL2026-06-01
00810179882464CopperfitCFEHAMSM2026-06-01
00810179882471CopperfitCFEHAMLXL2026-06-01
00810179881191CopperfitCFCWROS2024-11-18
00810179881245CopperfitCFRVWBR1SZ242024-11-18
00810179881252CopperfitCFAIRWROS2024-11-18
00810179881269CopperfitCFAIRAKOS2024-11-18
00810179881368CopperfitCFAIRWRSLP242024-11-18
00810179881573CopperfitCFAIRWRTHOS42024-11-18
00810179882440CopperFitCFIKNXXXL2026-01-13
00810179881924CopperfitCFRRHIP242025-03-05
00810179880439CopperfitCFRREL2025-01-28
00810179880040 CopperfitCFRRAKL1S32024-11-18
00810179880194 CopperfitCFRRBK1SZ2024-11-18
00810179880200CopperfitCFRRBKSM2024-11-18
00810179880217 CopperfitCFRRBKLXL2024-11-18
00810179880552CopperfitCFRRPASL2024-11-18
00810179880903CopperfitCFRRKNW2024-11-18
00810179880972CopperfitCFRRSHD2024-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178889723ViveVIVE HEALTH LLCITW2026-05-27
00810178889730ViveVIVE HEALTH LLCITW2026-05-27
00810178889747ViveVIVE HEALTH LLCITW2026-05-27
00810178889754ViveVIVE HEALTH LLCITW2026-05-27
00810178889761ViveVIVE HEALTH LLCITW2026-05-27
00810178889778ViveVIVE HEALTH LLCITW2026-05-27
00810178889785ViveVIVE HEALTH LLCITW2026-05-27
00810178889792ViveVIVE HEALTH LLCITW2026-05-27
00810178889808ViveVIVE HEALTH LLCITW2026-05-27
00810178889815ViveVIVE HEALTH LLCITW2026-05-27
00810178889822ViveVIVE HEALTH LLCITW2026-05-27
00810178889839ViveVIVE HEALTH LLCITW2026-05-27
00810178889846ViveVIVE HEALTH LLCITW2026-05-27
00810178889853ViveVIVE HEALTH LLCITW2026-05-27
00810178889860ViveVIVE HEALTH LLCITW2026-05-27
00810178889877ViveVIVE HEALTH LLCITW2026-05-27
00810178889884ViveVIVE HEALTH LLCITW2026-05-27
00810178889891ViveVIVE HEALTH LLCITW2026-05-27
00810178889907ViveVIVE HEALTH LLCITW2026-05-27
00810178889914ViveVIVE HEALTH LLCITW2026-05-27
00749756880169DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756880183DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888127DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888134DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888141DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888158DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00810113579801ViveVIVE HEALTH LLCITW2025-05-20
00810113579818ViveVIVE HEALTH LLCITW2025-05-20
00810113579429CoreTechVIVE HEALTH LLCITW2024-10-24
00810113579436CoreTechVIVE HEALTH LLCITW2024-10-24