FDA.reportPublic FDA data

Vive

Primary DI
00810113575476
Brand
Vive
Company
VIVE HEALTH LLC
Model
INS1059BLUS
Device description
Ergonomic Toe Separators (Small)
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
10810113575473PackageGS1120In Commercial Distribution
00810113575476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011357547310810113575473
00810113575476008101135754768101135754760810113575476

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
00810226442719ViveMOB1168GRYLTH2026-10-20
00810226442726ViveMOB1168GRYAC2026-10-20
00810226443006ViveSUP3194ORG362026-10-20
00810226443013ViveSUP3195BLKSM2026-10-20
00810226443020ViveSUP3195BLKLXL2026-10-20
00810226442825ViveSUP3190BLKS2026-10-15
00810226442832ViveSUP3190BLKM2026-10-15
00810226442849ViveSUP3190BLKL2026-10-15
00810226442979Vive CareRHB3085PAK102026-10-14
00810226442870ViveSUP3192BLKS2026-10-12
00810226442887ViveSUP3192BLKM2026-10-12
00810226442894ViveSUP3192BLKL2026-10-12
00810226442900ViveSUP3192BLKXL2026-10-12
00810226442917Vive BreatheLVA3196CLR10PAK2026-10-12
00810226442924ViveLVA1025PBU2026-10-12
00810226442931ViveLVA1025GBU2026-10-12
00810226442948ViveLVA1026PBU2026-10-12
00810226442955ViveLVA1026GBU2026-10-12
00810226442962ViveLVA3185BLKL2026-10-12
00810226440586ViveSUP3172BLKS2026-10-09

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
00810113575483ViveVIVE 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