FDA.reportPublic FDA data

VIVE

Primary DI
00810041981042
Brand
VIVE
Company
VIVE HEALTH LLC
Model
SUP2033
Device description
Short Pneumatic Walking Boot
Published
2020-01-09
Public version status
Update
Distribution status
Not 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
10810041981049PackageGS11Not in Commercial Distribution
00810041981042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198104910810041981049
00810041981042008100419810428100419810420810041981042

GMDN Terms#

Term, Definition table
TermDefinition
Assistive shoes/bootsA device specially designed/adapted to be worn on the feet of a person with a disability for walking and activities (e.g., sport). It is typically constructed with features that facilitate easy donning, fastening, and removal (e.g., special shape, elastic laces).

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
00810226442818ViveSUP3189BLK2026-10-01
00810226442788ViveLVA3082WHTGRY2026-09-30
00810226440944ViveCareRHB3080TAN462026-09-29
00810226440951ViveCareRHB3080TAN482026-09-29
00810226440968ViveCareRHB3080TAN4102026-09-29
00810226442542ViveCareRHB3080TAN46PAK12026-09-29
00810226442559ViveCareRHB3080TAN48PAK12026-09-29
00810226442566ViveCareRHB3080TAN410PAK12026-09-29
00810226442696ViveMOB1169BLK2026-09-29
00810178885329Vive CareRHB3071B10OZ2026-09-28
00810178889235ViveLVA3156BLK2026-09-28
00810178889280CoreTechSUP3128BLKS2026-05-05
00810178889297CoreTechSUP3128BLKM2026-05-05
00810178889303CoreTechSUP3128BLKL2026-05-05
00810178889310CoreTechSUP3128BLKXL2026-05-05
00810178889327CoreTechSUP3128BLK2XL2026-05-05
00810226442306ViveDMD1087CUFF2026-08-25
00810226442245ViveCSH1116GRY2026-08-21
00810226442290ViveLVA3188BLK2026-08-21
00810178889648CoreTechSUP3156BLK2026-08-19

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
00749756880169DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756880183DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888127DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888134DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888141DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02