FDA.reportPublic FDA data

VIVE

Primary DI
10818323026280
Brand
VIVE
Company
VIVE HEALTH LLC
Model
CSH1014
Device description
Wheelchair Cushion
Published
2019-02-01
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
KNOAccessories, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNOAccessories, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818323026280PackageGS16In Commercial Distribution
00818323026283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081832302628010818323026280
00818323026283008183230262838183230262830818323026283

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair cushionA padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair. It may be used to improve posture, provide back and/or side support, compensate for seat height, relieve stress points, and provide pressure alleviation for the buttocks, lumbar region, and the legs, and/or to provide an antislip mechanism. The device is typically situated behind the lower lumbar region of the back or under the buttocks and/or legs while the occupant is seated. 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
00810041982483ViveLVA2057BLU2026-05-14
00818323022797ViveLVA1003PAK2 2026-05-11
00818323025279ViveLVA10032026-05-11
00810113576817ViveLVA3049BLKML6M72024-07-17
00810113576824ViveLVA3049BLKCM92024-07-17
00810113576831ViveLVA3049BLKBM62024-07-17
00810113579627ViveLVA3078WHTS2025-04-04
00810113579634ViveLVA3078WHTM2025-04-04
00810113579641ViveLVA3078WHTL2025-04-04
00810113579658ViveLVA3078WHTL2025-04-04
00810178883516ViveLVA3099BLK2025-07-17
00818323025002VIVELVA1099BLK2019-03-24
00818323025019VIVELVA1099GRY2019-03-24
00818323025026VIVELVA1099PUR2019-03-24
00810178883639ViveLVA3102BLK2025-08-07
00810178883301ViveLVA3098BLK2025-07-17
00810178883523ViveLVA3100BLK2025-07-17
00810178883530ViveLVA3100PUR2025-07-17
00810178881857ViveLVA3086BLUS2025-07-15
00810178881864ViveLVA3086BLUM2025-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178884643ViveVIVE HEALTH LLCKNO2026-03-06
00810178884766ViveVIVE HEALTH LLCKNO2026-03-06
00810178884773ViveVIVE HEALTH LLCKNO2026-03-06
00810178884780ViveVIVE HEALTH LLCKNO2026-03-06
00810178884575ViveVIVE HEALTH LLCKNO2025-12-05
00810178884889ViveVIVE HEALTH LLCKNO2025-12-05
00810178884896ViveVIVE HEALTH LLCKNO2025-12-05
00810178884902ViveVIVE HEALTH LLCKNO2025-12-05
00840363373645AxiomKI MOBILITY, LLCKNO2025-12-04
00840363373706AxiomKI MOBILITY, LLCKNO2025-12-04
00840363373874AxiomKI MOBILITY, LLCKNO2025-12-04
00840363374680AxiomKI MOBILITY, LLCKNO2025-12-04
00840363374796AxiomKI MOBILITY, LLCKNO2025-12-04
00840363374871AxiomKI MOBILITY, LLCKNO2025-12-04
00840363375144AxiomKI MOBILITY, LLCKNO2025-12-04
00840363375441AxiomKI MOBILITY, LLCKNO2025-12-04
00840363369631AxiomKI MOBILITY, LLCKNO2025-12-02
00840363369693AxiomKI MOBILITY, LLCKNO2025-12-02
00840363370446AxiomKI MOBILITY, LLCKNO2025-12-02
00840363370545AxiomKI MOBILITY, LLCKNO2025-12-02
00840363370651AxiomKI MOBILITY, LLCKNO2025-12-02
00840363370811AxiomKI MOBILITY, LLCKNO2025-12-02
00840363371047AxiomKI MOBILITY, LLCKNO2025-12-02
00840363371054AxiomKI MOBILITY, LLCKNO2025-12-02
00840363371160AxiomKI MOBILITY, LLCKNO2025-12-02
00840363371337AxiomKI MOBILITY, LLCKNO2025-12-02
00840363369617AxiomKI MOBILITY, LLCKNO2025-12-02
00840363369624AxiomKI MOBILITY, LLCKNO2025-12-02
00840363369648AxiomKI MOBILITY, LLCKNO2025-12-02
00840363369655AxiomKI MOBILITY, LLCKNO2025-12-02