FDA.reportPublic FDA data

DRIVEMEDICAL

Primary DI
00822383928999
Brand
DRIVEMEDICAL
Company
Drive Devilbiss Healthcare
Model
KGA-1835-2G
Device description
"WenzeliteWheelchair Product Description: Kanga Solid Seat Pan, 18"", Adj Width"
Published
2019-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
INMCHAIR, WITH CASTERS
KNOACCESSORIES, WHEELCHAIR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INMChair, With CastersPhysical Medicine1
KNOAccessories, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822383928999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383928999008223839289998223839289990822383928999

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, occupant-driven, rear-wheels-operated, non-collapsibleA wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be manually propelled by the user while seated in the device. The occupant moves the device by rotating both rear wheels. The device cannot be folded or readily dismantled for transport.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
867673159
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20
00023601005168CAREX HEALTH BRANDSFGA51600 GRN2022-12-20
00023601005175CAREX HEALTH BRANDSFGA51700 BRNZ2022-12-20
00023601005182CAREX HEALTH BRANDSFGA51800 GRAY2022-12-20
00023601007117CAREX HEALTH BRANDSFGA71100 00002023-03-15
00023601007179CAREX HEALTH BRANDSFGA71700 00002023-03-15
00023601007186CAREX HEALTH BRANDSFGA71800 00002023-03-15
00023601007193CAREX HEALTH BRANDSFGA71900 00002023-03-15
00023601012210Carex Health BrandsFGA22100 00002022-12-09
00023601012227CAREX HEALTH BRANDSFGA22200 00002022-12-12
00023601012234CAREX HEALTH BRANDSFGA22300 00002022-12-12
00023601012302CAREX HEALTH BRANDSFGA23000 00002022-12-12
00023601012319CAREX HEALTH BRANDSFGA23177 00002022-12-12
00023601012333CAREX HEALTH BRANDSFGA23300 00002022-12-12
00023601013330CAREX HEALTH BRANDSFGA33300 00002022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193489028754GUARDIANMEDLINE INDUSTRIES, INC.INM2026-04-02
09420051798632Spex LimitedSPEX LIMITEDKNO2025-10-01
09420051798649Spex LimitedSPEX LIMITEDKNO2025-10-01
00810178883516ViveVIVE HEALTH LLCKNO2025-07-17
00810113579887ViveVIVE HEALTH LLCKNO2025-05-20
00810178880676ViveVIVE HEALTH LLCKNO2025-05-20
00810178880683ViveVIVE HEALTH LLCKNO2025-05-20
00810178880690ViveVIVE HEALTH LLCKNO2025-05-20
00810178882656ViveVIVE HEALTH LLCKNO2025-05-19
00810178882861ViveVIVE HEALTH LLCKNO2025-05-19
10197344111060MEDLINEMEDLINE INDUSTRIES, INC.INM2024-12-10
00197344129013MEDLINEMEDLINE INDUSTRIES, INC.INM2024-12-10
00810113578699ViveVIVE HEALTH LLCKNO2024-09-13
00810113578392Vive VIVE HEALTH LLCINM2024-09-05
00193489038265MEDLINEMEDLINE INDUSTRIES, INC.INM2024-08-06
00193489038258MEDLINEMEDLINE INDUSTRIES, INC.INM2024-07-31
00810113576817ViveVIVE HEALTH LLCKNO2024-07-17
00810113576824ViveVIVE HEALTH LLCKNO2024-07-17
00810113576831ViveVIVE HEALTH LLCKNO2024-07-17
M368IN601UWW1INTENSAGF HEALTH PRODUCTS, INC.INM2024-06-28
M368IN601UHNO1INTENSAGF HEALTH PRODUCTS, INC.INM2024-06-27
00810113576152ViveVIVE HEALTH LLCINM2024-06-12
00810113577463ViveVIVE HEALTH LLCINM2024-06-12
M368IN597G4271INTENSAGF HEALTH PRODUCTS, INC.INM2024-04-11
M368IN587WTL1INTENSAGF HEALTH PRODUCTS, INC.INM2024-03-28
M368IN587WTE1INTENSAGF HEALTH PRODUCTS, INC.INM2024-03-27
M368IN587WDOGPA1INTENSAGF HEALTH PRODUCTS, INC.INM2024-03-20
M368IN587WD9201PA1INTENSAGF HEALTH PRODUCTS, INC.INM2024-02-22
M368IN587WD92051INTENSAGF HEALTH PRODUCTS, INC.INM2024-02-22
M368IN587WD9205PA1INTENSAGF HEALTH PRODUCTS, INC.INM2024-02-22