FDA.reportPublic FDA data

Vive

Primary DI
00818323021196
Brand
Vive
Company
VIVE HEALTH LLC
Model
SUP1063M
Device description
Laced Ankle Brace (Medium)
Published
2019-03-15
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
ITWJoint, Ankle, External Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITWJoint, Ankle, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818323021193PackageGS120In Commercial Distribution
00818323021196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081832302119310818323021193
00818323021196008183230211968183230211960818323021196

GMDN Terms#

Term, Definition table
TermDefinition
Knee/ankle/foot orthosisAn externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee, ankle, and foot. 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
04719873009480"Esaote MyLabX1" Ultrasound Transducer_Convex Linear ArrayQISDA CORPORATIONITW2026-10-01
00749756397339DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-09-18
00749756397346DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-09-18
00810226440593CoreTechVIVE HEALTH LLCITW2026-07-16
00049696508384THERA PlusFOURSTAR GROUP INC.ITW2026-06-09
00810178889723ViveVIVE HEALTH LLCITW2026-05-27
00810178889730ViveVIVE HEALTH LLCITW2026-05-27
00810178889747ViveVIVE HEALTH LLCITW2026-05-27
00810178889754ViveVIVE HEALTH LLCITW2026-05-27
00810178889761ViveVIVE HEALTH LLCITW2026-05-27
00810178889778ViveVIVE HEALTH LLCITW2026-05-27
00810178889785ViveVIVE HEALTH LLCITW2026-05-27
00810178889792ViveVIVE HEALTH LLCITW2026-05-27
00810178889808ViveVIVE HEALTH LLCITW2026-05-27
00810178889815ViveVIVE HEALTH LLCITW2026-05-27
00810178889822ViveVIVE HEALTH LLCITW2026-05-27
00810178889839ViveVIVE HEALTH LLCITW2026-05-27
00810178889846ViveVIVE HEALTH LLCITW2026-05-27
00810178889853ViveVIVE HEALTH LLCITW2026-05-27
00810178889860ViveVIVE HEALTH LLCITW2026-05-27
00810178889877ViveVIVE HEALTH LLCITW2026-05-27
00810178889884ViveVIVE HEALTH LLCITW2026-05-27
00810178889891ViveVIVE HEALTH LLCITW2026-05-27
00810178889907ViveVIVE HEALTH LLCITW2026-05-27
00810178889914ViveVIVE HEALTH LLCITW2026-05-27
00810178888900CoreTechVIVE HEALTH LLCITW2026-05-05
00810178888917CoreTechVIVE HEALTH LLCITW2026-05-05
00810178888924CoreTechVIVE HEALTH LLCITW2026-05-05
00810178888931CoreTechVIVE HEALTH LLCITW2026-05-05
00810178888948CoreTechVIVE HEALTH LLCITW2026-05-05