FDA.reportPublic FDA data

Vive

Primary DI
00810113578408
Brand
Vive
Company
VIVE HEALTH LLC
Model
MOB1114
Device description
Leg Rest Heel Loop
Published
2024-09-05
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
IMWBrake, Extension, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMWBrake, Extension, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810113578405PackageGS1100In Commercial Distribution
00810113578408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011357840510810113578405
00810113578408008101135784088101135784080810113578408

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair brake extensionA metal lever with handle designed to be attached to an existing wheelchair brake lever, to improve handling/leverage for a wheelchair occupant who has difficulty operating the standard brake lever.

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
00810226442535ViveLVA3192BLK2026-10-23
00810226442856ViveSUP3191BLK12CT2026-10-23
00810226443136ViveLVA3198BLK2PAK2026-10-23
00810226443068ViveLVA1006GBU2026-10-22
00810226443075ViveLVA1006PBU2026-10-22
00810226443082ViveSUP3196BLKSM2026-10-22
00810226443099ViveSUP3196BLKLXL2026-10-22
00810226443037ViveMOB1170BLK2026-10-21
00810226443044ViveMOB1170PUR2026-10-21
00810226443051ViveMOB1170TAL2026-10-21
00810226442719ViveMOB1168GRYLTH2026-10-20
00810226442726ViveMOB1168GRYAC2026-10-20
00810226443006ViveSUP3194ORG362026-10-20
00810226443013ViveSUP3195BLKSM2026-10-20
00810226443020ViveSUP3195BLKLXL2026-10-20
00810226442825ViveSUP3190BLKS2026-10-15
00810226442832ViveSUP3190BLKM2026-10-15
00810226442849ViveSUP3190BLKL2026-10-15
00810226442979Vive CareRHB3085PAK102026-10-14
00810226442870ViveSUP3192BLKS2026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013569822ValmaxSupply Line MedicalIMW2025-02-21
00841447114963WHEEL LOCK EXTENSIONS 6 ININVACARE CORPORATIONIMW2024-07-25
00733657229899TIPS WC BRAKE EXTENSION YELLOW PK/12 SLOTTED STYLEALIMED, INC.IMW2022-12-01
00606509900201WHEELCHAIR BRAKESPride Mobility Products CorpIMW2019-08-26