FDA.reportPublic FDA data

ViveSole

Primary DI
00818323025590
Brand
ViveSole
Company
VIVE HEALTH LLC
Model
INS1014BLUS
Device description
Toe Separators (Blue) Small
Published
2023-01-02
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
10818323025597PackageGS1120In Commercial Distribution
00818323025590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081832302559710818323025597
00818323025590008183230255908183230255900818323025590

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
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
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
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