FDA.reportPublic FDA data

Copperfit

Primary DI
00810179880460
Brand
Copperfit
Company
Ideavillage Products Corp
Model
CFACB1SZ
Device description
CopperFit Arch Compression Band OS BLACK
Published
2024-11-18
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
00810179880460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810179880460008101798804608101798804600810179880460

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.

Sterilization Methods#

Method table
Method

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
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