FDA.reportPublic FDA data

CopperFit

Primary DI
00810179882068
Brand
CopperFit
Company
Ideavillage Products Corp
Model
CFSAUNBLXL24
Device description
CopperFit Sauna Belt 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
IQIOrthosis, Limb Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810179882068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810179882068008101798820688101798820680810179882068

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
Premarket exempt
true
Serial number
true
Contains natural rubber latex
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
00810179882464CopperfitIdeavillage Products CorpIQI2026-06-01
00810179882471CopperfitIdeavillage Products CorpIQI2026-06-01
00810079192656Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192663Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192670Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192687Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192694Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192700Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192717Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192724Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192731Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192748Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192755Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192762Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192779Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192786Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192793Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192809Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192816Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192823Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192946Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192953Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192960Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192977Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192984Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192991Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079193004Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079193011Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079193028Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00636257213322MEDIMEDI MANUFACTURING, INC.IQI2026-04-24