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
00810226440104ViveLVA3167BLK2026-06-04
00810226440111ViveLVA3167BLKPAK22026-06-04
00810178889969ViveLVA3166WHT2026-06-03
00810178889976ViveLVA3164BBB2026-06-03
00810178889983ViveLVA3164BBP2026-06-03
00810178889990ViveLVA3164BGN2026-06-03
00810226440005ViveLVA3165BB2026-06-03
00810226440012ViveLVA3165BP2026-06-03
00810226440029ViveLVA3165GN2026-06-03
00810226440036ViveSUP3008BLU2026-06-03
00810226440043ViveSUP3008PNK2026-06-03
00810178889624Vive BreatheLVA31612026-06-01
00810178889921ViveCareRHB3079S100CT2026-05-29
00810178889938ViveCareRHB3079M100CT2026-05-29
00810178889945ViveCareRHB3079L50CT2026-05-29
00810178889723ViveSUP3158BLKXS2026-05-27
00810178889730ViveSUP3158BLKS2026-05-27
00810178889747ViveSUP3158BLKM2026-05-27
00810178889754ViveSUP3158BLKL2026-05-27
00810178889761ViveSUP3158BLKXL2026-05-27

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