FDA.reportPublic FDA data

Vive

Primary DI
00810113575483
Brand
Vive
Company
VIVE HEALTH LLC
Model
INS1059BLUM
Device description
Ergonomic Toe Separators (Medium)
Published
2024-01-12
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
OHIOrthosis, Foot Drop

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHIOrthosis, Foot DropPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810113575480PackageGS1120In Commercial Distribution
00810113575483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011357548010810113575480
00810113575483008101135754838101135754830810113575483

GMDN Terms#

Term, Definition table
TermDefinition
Toe separatorA foot-worn device designed to space the toes of the foot to relieve pain, pressure/friction between toes, and/or to facilitate realignment of the toes to a natural position. It is made of soft materials (e.g., silicone, polymer gel) and may be available in a variety of forms (e.g., circular channels moulded together, small disks, half moon shape); some types are in addition intended to protect and/or reduce bunion or Tailor’s bunion formation. 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
00810178888900CoreTechSUP3137BLKXS2026-05-05
00810178888917CoreTechSUP3137BLKS2026-05-05
00810178888924CoreTechSUP3137BLKM2026-05-05
00810178888931CoreTechSUP3137BLKL2026-05-05
00810178888948CoreTechSUP3137BLKXL2026-05-05
00810178888955CoreTechSUP3135BLKXS2026-05-05
00810178888962CoreTechSUP3135BLKS2026-05-05
00810178888979CoreTechSUP3135BLKM2026-05-05
00810178888986CoreTechSUP3135BLKL2026-05-05
00810178888993CoreTechSUP3135BLKXL2026-05-05
00810178889006CoreTechSUP3138BLKXS2026-05-05
00810178889013CoreTechSUP3138BLKS2026-05-05
00810178889020CoreTechSUP3138BLKM2026-05-05
00810178889037CoreTechSUP3138BLKL2026-05-05
00810178889044CoreTechSUP3138BLKXL2026-05-05
00810178889082CoreTechSUP3136BLKXS2026-05-05
00810178889099CoreTechSUP3136BLKS2026-05-05
00810178889105CoreTechSUP3136BLKM2026-05-05
00810178889112CoreTechSUP3136BLKL2026-05-05
00810178889129CoreTechSUP3136BLKXL2026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226441019ViveSoleVIVE HEALTH LLCOHI2026-07-13
00810226441026ViveSoleVIVE HEALTH LLCOHI2026-07-13
00810178883219ViveVIVE HEALTH LLCOHI2026-02-09
00810178883226ViveVIVE HEALTH LLCOHI2026-02-09
00810178883233ViveVIVE HEALTH LLCOHI2026-02-09
00810113575476ViveVIVE HEALTH LLCOHI2024-01-12
00810113575490ViveVIVE HEALTH LLCOHI2024-01-12
10810113575473ViveVIVE HEALTH LLCOHI2024-01-12
10810113575480ViveVIVE HEALTH LLCOHI2024-01-12
10810113575497ViveVIVE HEALTH LLCOHI2024-01-12
00810050250771Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
00810050250788Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
00810050250795Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
00810050250801Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
00810050250818Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
00810050250825Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
00810050250832Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
00810050250849Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
G144AFO0Flint RehabFlint Rehabilitation Devices LLCOHI2023-08-10
G505MRES0Easy StepM.A.S.S. Rehab, LLCOHI2023-08-01
00810113573830VIVEVIVE HEALTH LLCOHI2023-07-24
00810113573847VIVEVIVE HEALTH LLCOHI2023-07-24
00810113573854VIVEVIVE HEALTH LLCOHI2023-07-24
10810113573837VIVEVIVE HEALTH LLCOHI2023-07-24
10810113573844VIVEVIVE HEALTH LLCOHI2023-07-24
10810113573851VIVEVIVE HEALTH LLCOHI2023-07-24
00810041989055ViveSoleVIVE HEALTH LLCOHI2023-06-23
00810041989062ViveSoleVIVE HEALTH LLCOHI2023-06-23
00810041989079ViveSoleVIVE HEALTH LLCOHI2023-06-23
00810113573076ViveSoleVIVE HEALTH LLCOHI2023-06-23