FDA.reportPublic FDA data

Vive

Primary DI
00810178880591
Brand
Vive
Company
VIVE HEALTH LLC
Model
SUP3100BLKS
Device description
Post Op Shoe Round Toe (Small)
Published
2025-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IPGShoe, Cast

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPGShoe, CastPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810178880591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810178880591008101788805918101788805910810178880591

GMDN Terms#

Term, Definition table
TermDefinition
Orthotic shoe, non-customizedA prefabricated (non-customized) footwear designed as a shoe intended to support, align, prevent, and compensate for or correct deformities of the feet to help improve function and/or for post-operative therapy. This is a reusable device.

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810226440104ViveLVA3167BLK2026-06-04
00810226440111ViveLVA3167BLKPAK22026-06-04
00810178889969ViveLVA3166WHT2026-06-03
00810178889976ViveLVA3164BBB2026-06-03
00810178889983ViveLVA3164BBP2026-06-03
00810178889990ViveLVA3164BGN2026-06-03
00810226440005ViveLVA3165BB2026-06-03
00810226440012ViveLVA3165BP2026-06-03
00810226440029ViveLVA3165GN2026-06-03
00810226440036ViveSUP3008BLU2026-06-03
00810226440043ViveSUP3008PNK2026-06-03
00810178889624Vive BreatheLVA31612026-06-01
00810178889921ViveCareRHB3079S100CT2026-05-29
00810178889938ViveCareRHB3079M100CT2026-05-29
00810178889945ViveCareRHB3079L50CT2026-05-29
00810178889723ViveSUP3158BLKXS2026-05-27
00810178889730ViveSUP3158BLKS2026-05-27
00810178889747ViveSUP3158BLKM2026-05-27
00810178889754ViveSUP3158BLKL2026-05-27
00810178889761ViveSUP3158BLKXL2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756888349DeRoyalDEROYAL INDUSTRIES, INC.IPG2026-04-02
00749756888356DeRoyalDEROYAL INDUSTRIES, INC.IPG2026-04-02
00749756888370DeRoyalDEROYAL INDUSTRIES, INC.IPG2026-04-02
00749756888387DeRoyalDEROYAL INDUSTRIES, INC.IPG2026-04-02
00749756888394DeRoyalDEROYAL INDUSTRIES, INC.IPG2026-04-02
00749756888400DeRoyalDEROYAL INDUSTRIES, INC.IPG2026-04-02
00810178880577Vive VIVE HEALTH LLCIPG2025-10-14
00810178880584Vive VIVE HEALTH LLCIPG2025-10-14
00810178880607Vive VIVE HEALTH LLCIPG2025-10-14
00810178880614Vive VIVE HEALTH LLCIPG2025-10-14
00810178880621Vive VIVE HEALTH LLCIPG2025-10-14
00810178880638Vive VIVE HEALTH LLCIPG2025-10-14
G0648317270026770GAITKEEPER® Cast Shoe POSITION HEALTH, LLCIPG2024-08-27
G0648317270026840GAITKEEPER® Cast Shoe POSITION HEALTH, LLCIPG2024-08-27
G0648317270026910GAITKEEPER® Cast Shoe POSITION HEALTH, LLCIPG2024-08-27
G0648317270027520Position Health® Classic Post-Op Shoe POSITION HEALTH, LLCIPG2024-08-27
G0648317270027690Position Health® Classic Post-Op ShoePOSITION HEALTH, LLCIPG2024-08-27
G0648317270027760Position Health® Classic Post-Op ShoePOSITION HEALTH, LLCIPG2024-08-27
G0648317270027830Position Health® Classic Post-Op ShoePOSITION HEALTH, LLCIPG2024-08-27
G0648317270027900Position Health® Classic Post-Op ShoePOSITION HEALTH, LLCIPG2024-08-27
00810113576398CoreTechVIVE HEALTH LLCIPG2024-06-10
00810113576404CoreTechVIVE HEALTH LLCIPG2024-06-10
00810113576411CoreTechVIVE HEALTH LLCIPG2024-06-10
00810113576428CoreTechVIVE HEALTH LLCIPG2024-06-10
10810113576395CoreTechVIVE HEALTH LLCIPG2024-06-10
10810113576401CoreTechVIVE HEALTH LLCIPG2024-06-10
10810113576418CoreTechVIVE HEALTH LLCIPG2024-06-10
10810113576425CoreTechVIVE HEALTH LLCIPG2024-06-10
00810113575971VIVEVIVE HEALTH LLCIPG2024-06-05
10810113575978VIVEVIVE HEALTH LLCIPG2024-06-05