FDA.reportPublic FDA data

Vive

Primary DI
00810226442832
Brand
Vive
Company
VIVE HEALTH LLC
Model
SUP3190BLKM
Device description
Achilles Tendonitis Strap (Medium)
Published
2026-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
00810226442832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810226442832008102264428328102264428320810226442832

GMDN Terms#

Term, Definition table
TermDefinition
Foot orthosisA device designed to encompass the whole or part of the foot, or designed as a plantar insert, and intended to provide rigid or semi-rigid correction of the foot for persons with orthopaedic deformities/injuries of the feet; it may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds. It is typically made of metal, synthetic, and/or textile materials and may include customizable plantar inserts. This is a single-patient use device that can be reapplied to the patient during the treatment period (reusable) before being discarded.

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810226442825ViveSUP3190BLKS2026-10-15
00810226442849ViveSUP3190BLKL2026-10-15
00810226442979Vive CareRHB3085PAK102026-10-14
00810226442870ViveSUP3192BLKS2026-10-12
00810226442887ViveSUP3192BLKM2026-10-12
00810226442894ViveSUP3192BLKL2026-10-12
00810226442900ViveSUP3192BLKXL2026-10-12
00810226442917Vive BreatheLVA3196CLR10PAK2026-10-12
00810226442924ViveLVA1025PBU2026-10-12
00810226442931ViveLVA1025GBU2026-10-12
00810226442948ViveLVA1026PBU2026-10-12
00810226442955ViveLVA1026GBU2026-10-12
00810226442962ViveLVA3185BLKL2026-10-12
00810226440586ViveSUP3172BLKS2026-10-09
00810226442610ViveRHB3084RM2026-10-09
00810226442627ViveRHB3084RL2026-10-09
00810226442634ViveRHB3084LL2026-10-09
00810226442641ViveRHB3084LM2026-10-09
00810226442757ViveSUP3172BLKM2026-10-09
00810226442764ViveSUP3172BLKL2026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226442825ViveVIVE HEALTH LLCITW2026-10-15
00810226442849ViveVIVE HEALTH LLCITW2026-10-15
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