FDA.reportPublic FDA data

VIVE

Primary DI
10818323029588
Brand
VIVE
Company
VIVE HEALTH LLC
Model
MOB1033
Device description
Upright Walker BLK
Published
2019-10-02
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
ITJWalker, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITJWalker, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818323029588PackageGS11In Commercial Distribution
00818323029581PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081832302958810818323029588
00818323029581008183230295818183230295810818323029581

GMDN Terms#

Term, Definition table
TermDefinition
Basic walker, foldableAn all- or partially-wheeled mobility aid in the form of a waist-high, foldable framework with handgrips and four or three legs designed to provide a stable support to a person with a disability, a geriatric or an infirm person when standing or ambulating; it may also be used during rehabilitation. It is constructed of lightweight metal, plastic, and rubber materials and in the form of a mobile support structure which the user holds and pushes in front of them as they walk. It is foldable for storage and transportation, and includes a braking mechanism; it may be width-adjustable and some types may include a seat on which the user can rest.

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
00818323026702ViveLVA1077PK482024-01-12
00818323026719ViveLVA1077PK722024-01-12
00810226441385ViveLVA3177BLK2026-07-28
00810178883127ViveSUP3108S2026-07-21
00810178883134ViveSUP3108M2026-07-21
00810178883141ViveSUP3108L2026-07-21
00810178883158ViveSUP3108XL2026-07-21
00810226441217ViveLVA3173WOOD2026-07-21
00810226441224SuresLVA3174BFL2026-07-21
00810226441231SuresLVA3174BLK2026-07-21
00810226441248SuresLVA3174RPF2026-07-21
00810178889334SuresLVA2040NAV2026-07-17
00810178889341SuresLVA2040NAV2PAK2026-07-17
00810178889358SuresLVA2040NAV4PAK2026-07-17
00810226441156SuresLVA2040BLK2026-07-17
00810226441163SuresLVA2040BLK2PAK2026-07-17
00810226441170SuresLVA2040BLK4PAK2026-07-17
00810226441187SuresLVA2040TAN2026-07-17
00810226441194SuresLVA2040TAN2PAK2026-07-17
00810226441200SuresLVA2040TAN4PAK2026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860001638721PerfectFit Standard RollatorCarrier Medical LLCITJ2026-07-13
00860001638783PerfectFit Heavy Duty RollatorCarrier Medical LLCITJ2026-07-13
00860001638790Phantom Knee WalkerCarrier Medical LLCITJ2026-07-13
00860014392702ICON Heavy Duty RollatorCarrier Medical LLCITJ2026-07-13
00860014392719ICON Standard RollatorCarrier Medical LLCITJ2026-07-13
00860014392726AirLite Standard RollatorCarrier Medical LLCITJ2026-07-13
04719876190253TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.ITJ2026-07-08
00841447116547Invacare Essentials RollatorINVACARE CORPORATIONITJ2026-07-01
00194346283439EquateDrive Devilbiss HealthcareITJ2026-06-10
00199536930186BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930193BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930209BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930216BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930223BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
14895262504259SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504266SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504273SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504280SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504693HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504709HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504716HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504730HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
24895262504324SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
54895262504226HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
54895262504233HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
54895262504240HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
08054040402432GRILLOORMESA SRLITJ2025-09-15
08054040402449GRILLOORMESA SRLITJ2025-09-15
08054040402463GRILLOORMESA SRLITJ2025-09-15
08054040402470GRILLOORMESA SRLITJ2025-09-15