FDA.reportPublic FDA data

VIVE

Primary DI
10818323028321
Brand
VIVE
Company
VIVE HEALTH LLC
Model
RHB2000
Device description
Foot Stretcher
Published
2019-07-17
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
OHIOrthosis, Foot Drop

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818323028321PackageGS142In Commercial Distribution
00818323028324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081832302832110818323028321
00818323028324008183230283248183230283240818323028324

GMDN Terms#

Term, Definition table
TermDefinition
Paediatric dorsiflexion slant boardA standing platform for a child designed to slant the surface on which the feet are placed to create a slope angle to therapeutically stretch the ankle plantar flexion muscles/tendons. It is intended to be used in the treatment of various medical conditions (e.g., congenital, neurological, post-traumatic) where tendon tightness and muscle contracture affect the ability to dorsiflex the foot, possibly leading to an abnormal gait. It is typically made of synthetic polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method

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
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
00810226441019ViveSoleVIVE HEALTH LLCOHI2026-07-13
00810226441026ViveSoleVIVE HEALTH LLCOHI2026-07-13
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
00810113573854VIVEVIVE 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