FDA.reportPublic FDA data

Vive

Primary DI
10818323029687
Brand
Vive
Company
VIVE HEALTH LLC
Model
RHB2011BLKXL
Device description
Heel Wedge Post Op Shoe (XL)
Published
2023-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
10818323029687PackageGS124In Commercial Distribution
00818323029680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081832302968710818323029687
00818323029680008183230296808183230296800818323029680

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810178889723ViveSUP3158BLKXS2026-05-27
00810178889730ViveSUP3158BLKS2026-05-27
00810178889747ViveSUP3158BLKM2026-05-27
00810178889754ViveSUP3158BLKL2026-05-27
00810178889761ViveSUP3158BLKXL2026-05-27
00810178889778ViveSUP3159BLKXS2026-05-27
00810178889785ViveSUP3159BLKS2026-05-27
00810178889792ViveSUP3159BLKM2026-05-27
00810178889808ViveSUP3159BLKL2026-05-27
00810178889815ViveSUP3159BLKXL2026-05-27
00810178889822ViveSUP3160BLKXS2026-05-27
00810178889839ViveSUP3160BLKS2026-05-27
00810178889846ViveSUP3160BLKM2026-05-27
00810178889853ViveSUP3160BLKL2026-05-27
00810178889860ViveSUP3160BLKXL2026-05-27
00810178889877ViveSUP3161BLKXS2026-05-27
00810178889884ViveSUP3161BLKS2026-05-27
00810178889891ViveSUP3161BLKM2026-05-27
00810178889907ViveSUP3161BLKL2026-05-27
00810178889914ViveSUP3161BLKXL2026-05-27

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
00810178880591Vive 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