FDA.reportPublic FDA data

CopperFit

Primary DI
00810179882174
Brand
CopperFit
Company
Ideavillage Products Corp
Model
LCGLVCHSM
Device description
CF Mobilizer Gloves SM
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
ILHSplint, Hand, And Components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810179882174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810179882174008101798821748101798821740810179882174

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure gloveA device in the form of a short or long glove intended to tightly fit over the hand(s) to apply compression/pressure (i.e., graduated or even-force), typically to control oedema, swelling and/or scarring due to arthritis or injuries, and/or to manage lymphoedema; it is not a strip/roll binder, shirt or tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex) and may be available with openings for fingers and/or with integrated sleeves that may reach the wrist, elbow, or axilla; 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
Contains natural rubber latex
true

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226443006ViveVIVE HEALTH LLCILH2026-10-20
00194346210794EquateWAL-MART STORES, INC.ILH2026-10-14
00810226442870ViveVIVE HEALTH LLCILH2026-10-12
00810226442887ViveVIVE HEALTH LLCILH2026-10-12
00810226442894ViveVIVE HEALTH LLCILH2026-10-12
00810226442900ViveVIVE HEALTH LLCILH2026-10-12
00810179882365CopperFitIdeavillage Products CorpILH2026-10-01
00810179882372CopperFitIdeavillage Products CorpILH2026-10-01
00810179882662CopperFitIdeavillage Products CorpILH2026-10-01
00810179882679CopperFitIdeavillage Products CorpILH2026-10-01
50609576700274Puritan®Puritan Medical ProductsILH2026-07-27
06974546525140TealmedNingbo Tealmed Emergency Products Co., Ltd.ILH2026-06-25
00810226440036ViveVIVE HEALTH LLCILH2026-06-03
00810226440043ViveVIVE HEALTH LLCILH2026-06-03
00057475274139BIOS LivingThermor LtdILH2023-09-18
00057475274313BIOS LivingThermor LtdILH2023-09-18
00057475210175BIOS LivingThermor LtdILH2023-09-15
00057475210182BIOS LivingThermor LtdILH2023-09-15
10680651299854HalyardO&M HALYARD, INC.ILH2023-07-31
20680651299004HalyardO&M HALYARD, INC.ILH2023-06-07
B7685810200Buxton BioMedicalBUXTON BIOMEDICAL, INC.ILH2023-05-26
00057475210441BIOS LivingThermor LtdILH2023-03-31
00057475210472BIOS LivingThermor LtdILH2023-03-31
00609271100053DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100152DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100251DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100350DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100459DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101050DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101159DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08