FDA.reportPublic FDA data

ViveSole

Primary DI
00810041981066
Brand
ViveSole
Company
VIVE HEALTH LLC
Model
INS1028DBL
Device description
Double Toe Splint
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
FMPProtector, Skin Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810041981063PackageGS1150In Commercial Distribution
00810041981066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198106310810041981063
00810041981066008100419810668100419810660810041981066

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
00810226442535ViveLVA3192BLK2026-10-23
00810226442856ViveSUP3191BLK12CT2026-10-23
00810226443136ViveLVA3198BLK2PAK2026-10-23
00810226443068ViveLVA1006GBU2026-10-22
00810226443075ViveLVA1006PBU2026-10-22
00810226443082ViveSUP3196BLKSM2026-10-22
00810226443099ViveSUP3196BLKLXL2026-10-22
00810226443037ViveMOB1170BLK2026-10-21
00810226443044ViveMOB1170PUR2026-10-21
00810226443051ViveMOB1170TAL2026-10-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00089904011510Action®ACTION PRODUCTS, INC.FMP2026-10-14
00089904011527Action®ACTION PRODUCTS, INC.FMP2026-10-14
00850018561037Gel-E DonutINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561044Gel-E DonutINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561051Gel-E DonutINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561068SquishonINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561075SquishonINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561082SquishonINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00089904011503Action®ACTION PRODUCTS, INC.FMP2026-09-30
07333350181475Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350455873Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350647292Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350743918Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350775360Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350462161Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350529079Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350768249Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
00860015694713Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694720Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694737Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694744Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694751Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694768Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00089904011459Action®ACTION PRODUCTS, INC.FMP2026-07-23
00089904011435Action®ACTION PRODUCTS, INC.FMP2026-07-21
00089904011442Action®ACTION PRODUCTS, INC.FMP2026-07-21
00609271999336Aircore™ Offloading InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999343Aircore™ Offloading InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999374Aircore™ Offloading InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999381Aircore™ Offloading InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20