FDA.reportPublic FDA data

VIVE

Primary DI
00810113573854
Brand
VIVE
Company
VIVE HEALTH LLC
Model
SUP3040BLKL
Device description
Plantar Fasciitis Stretch Splint (Large)
Published
2023-07-24
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
OHIOrthosis, Foot Drop

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHIOrthosis, Foot DropPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810113573851PackageGS180In Commercial Distribution
00810113573854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011357385110810113573851
00810113573854008101135738548101135738540810113573854

GMDN Terms#

Term, Definition table
TermDefinition
Ankle/foot orthosisA prefabricated (non-customized) externally applied and wearable appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. 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, and may include patient adaptable plantar inserts. 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
00810178889723ViveSUP3158BLKXS2026-05-27
00810178889730ViveSUP3158BLKS2026-05-27
00810178889747ViveSUP3158BLKM2026-05-27
00810178889754ViveSUP3158BLKL2026-05-27
00810178889761ViveSUP3158BLKXL2026-05-27
00810178889778ViveSUP3159BLKXS2026-05-27
00810178889785ViveSUP3159BLKS2026-05-27
00810178889792ViveSUP3159BLKM2026-05-27
00810178889808ViveSUP3159BLKL2026-05-27
00810178889815ViveSUP3159BLKXL2026-05-27
00810178889822ViveSUP3160BLKXS2026-05-27
00810178889839ViveSUP3160BLKS2026-05-27
00810178889846ViveSUP3160BLKM2026-05-27
00810178889853ViveSUP3160BLKL2026-05-27
00810178889860ViveSUP3160BLKXL2026-05-27
00810178889877ViveSUP3161BLKXS2026-05-27
00810178889884ViveSUP3161BLKS2026-05-27
00810178889891ViveSUP3161BLKM2026-05-27
00810178889907ViveSUP3161BLKL2026-05-27
00810178889914ViveSUP3161BLKXL2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178883219ViveVIVE HEALTH LLCOHI2026-02-09
00810178883226ViveVIVE HEALTH LLCOHI2026-02-09
00810178883233ViveVIVE HEALTH LLCOHI2026-02-09
00810113575476ViveVIVE HEALTH LLCOHI2024-01-12
00810113575483ViveVIVE HEALTH LLCOHI2024-01-12
00810113575490ViveVIVE HEALTH LLCOHI2024-01-12
10810113575473ViveVIVE HEALTH LLCOHI2024-01-12
10810113575480ViveVIVE HEALTH LLCOHI2024-01-12
10810113575497ViveVIVE HEALTH LLCOHI2024-01-12
00810050250771Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
00810050250788Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
00810050250795Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
00810050250801Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
00810050250818Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
00810050250825Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
00810050250832Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
00810050250849Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
G144AFO0Flint RehabFlint Rehabilitation Devices LLCOHI2023-08-10
G505MRES0Easy StepM.A.S.S. Rehab, LLCOHI2023-08-01
00810113573830VIVEVIVE HEALTH LLCOHI2023-07-24
00810113573847VIVEVIVE HEALTH LLCOHI2023-07-24
10810113573837VIVEVIVE HEALTH LLCOHI2023-07-24
10810113573844VIVEVIVE HEALTH LLCOHI2023-07-24
10810113573851VIVEVIVE HEALTH LLCOHI2023-07-24
00810041989055ViveSoleVIVE HEALTH LLCOHI2023-06-23
00810041989062ViveSoleVIVE HEALTH LLCOHI2023-06-23
00810041989079ViveSoleVIVE HEALTH LLCOHI2023-06-23
00810113573076ViveSoleVIVE HEALTH LLCOHI2023-06-23
00810113573083ViveSoleVIVE HEALTH LLCOHI2023-06-23
00810113573090ViveSoleVIVE HEALTH LLCOHI2023-06-23