FDA.reportPublic FDA data

ViveSole

Primary DI
00810113571294
Brand
ViveSole
Company
VIVE HEALTH LLC
Model
INS1023PNKXS
Device description
Gel Heel Cups (Pink) XS
Published
2022-12-28
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
KYSInsoles, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYSInsoles, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810113571291PackageGS172In Commercial Distribution
00810113571294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011357129110810113571291
00810113571294008101135712948101135712940810113571294

GMDN Terms#

Term, Definition table
TermDefinition
Orthotic insole, prefabricated, non-antimicrobialA prefabricated shoe insert typically available for use by a layperson intended to provide supplemental support for the arch and/or heel of the foot; it does not include an antimicrobial agent(s). 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
00810179882266CopperfitIdeavillage Products CorpKYS2026-10-01
00810179882273CopperfitIdeavillage Products CorpKYS2026-10-01
00810179882280CopperfitIdeavillage Products CorpKYS2026-10-01
00810179882297CopperfitIdeavillage Products CorpKYS2026-10-01
04744946011787ESTCARBON Erismet OUKYS2024-10-29
04744946011794ESTCARBON Erismet OUKYS2024-10-29
04744946011800ESTCARBON Erismet OUKYS2024-10-29
04744946011817ESTCARBON Erismet OUKYS2024-10-29
04744946011824ESTCARBON Erismet OUKYS2024-10-29
04744946011831ESTCARBON Erismet OUKYS2024-10-29
04744946011848ESTCARBON Erismet OUKYS2024-10-29
04744946011923ESTCARBON Erismet OUKYS2024-10-29
04744946011770ESTCARBON Erismet OUKYS2024-10-28
04744946011749ESTCARBON Erismet OUKYS2024-09-20
04744946011756ESTCARBON Erismet OUKYS2024-09-20
04744946011763ESTCARBON Erismet OUKYS2024-09-20
04744946010094ESTCARBON Erismet OUKYS2024-09-09
04744946010100ESTCARBON Erismet OUKYS2024-09-09
04744946010209ESTCARBON Erismet OUKYS2024-09-09
04744946010308ESTCARBON Erismet OUKYS2024-09-09
04744946011886ESTCARBON Erismet OUKYS2024-09-09
04744946011893ESTCARBON Erismet OUKYS2024-09-09
04744946011909ESTCARBON Erismet OUKYS2024-09-09
04744946011930ESTCARBON Erismet OUKYS2024-09-09
04744946011947ESTCARBON Erismet OUKYS2024-09-09
04744946011954ESTCARBON Erismet OUKYS2024-09-09
04744946011961ESTCARBON Erismet OUKYS2024-09-09
04744946011978ESTCARBON Erismet OUKYS2024-09-09
04744946012111ESTCARBON Erismet OUKYS2024-09-09
04744946012128ESTCARBON Erismet OUKYS2024-09-09