FDA.reportPublic FDA data

Vive

Primary DI
00810178880614
Brand
Vive
Company
VIVE HEALTH LLC
Model
SUP3100BLKL
Device description
Post Op Shoe Round Toe (Large)
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
00810178880614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810178880614008101788806148101788806140810178880614

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
00810226440593CoreTechSUP31702026-07-16
00818323020014ViveLVA10412026-07-16
00810226440623ViveSUP3168BGES2026-07-14
00810226440630ViveSUP3168BGEM2026-07-14
00810226440647ViveSUP3168BGEL2026-07-14
00810226440654ViveSUP3168BGEXL2026-07-14
00810226440661ViveSUP3168BGE2XL2026-07-14
00810226440678ViveSUP3168BLKS2026-07-14
00810226440685ViveSUP3168BLKM2026-07-14
00810226440692ViveSUP3168BLKL2026-07-14
00810226440708ViveSUP3168BLKXL2026-07-14
00810226440715ViveSUP3168BLK2XL2026-07-14
00810226440739ViveSUP3173BLKS2026-07-14
00810226440746ViveSUP3173BLKM2026-07-14
00810226440753ViveSUP3173BLKL2026-07-14
00810226440760ViveSUP3173BLKXL2026-07-14
00810226440777ViveSUP3173BLK2XL2026-07-14
00810226440784ViveSUP3173BGES2026-07-14
00810226440791ViveSUP3173BGEM2026-07-14
00810226440807ViveSUP3173BGEL2026-07-14

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
00810178880591Vive VIVE HEALTH LLCIPG2025-10-14
00810178880607Vive 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