FDA.reportPublic FDA data

DRIVEMEDICAL

Primary DI
00822383928937
Brand
DRIVEMEDICAL
Company
Drive Devilbiss Healthcare
Model
KGA-FR-AA
Device description
WenzeliteWheelchair Product Description: Kanga Adult Footrests, Adj Angle, Pr.
Published
2019-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IMMFOOTREST, WHEELCHAIR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMMFootrest, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822383928937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383928937008223839289378223839289370822383928937

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
00822383012155Silver Sport 16" ReclBackSSP16RBDDAV2026-02-03
00822383012162Silver Sport 16" Full ArmSSP16RBDFAV2026-02-03
00822383012179Silver Sport 18" Det DeskSSP18RBDDAV2026-02-03
00822383012186Silver Sport 18" Full ArmSSP18RBDFAV2026-02-03
00822383012193Silver Sport 20" Det DeskSSP20RBDDAV2026-02-03
00822383012209Silver Sport 20" Full ArmSSP20RBDFAV2026-02-03
00822383034683Silver Sport HD 22"SSP22RBDDAV2026-02-03
00822383034690Silver Sport 24" HDSSP24RBDDAV2026-02-03
00822383030135AeroFly Wheelchair, 18”, Black, SFAF18FDABK-SF2025-11-18
00822383030142AeroFly Wheelchair, 18”, Gray, SFAF18FDAGY-SF2025-11-18
00822383033204AeroFly Wheelchair 20:, Black, SFAF20FDABK-SF2025-11-11
00822383033211AeroFly Wheelchair 20:, Gray, SFAF20FDAGY-SF2025-11-11
00822383033228AeroFly Transport Chair, 18", BlackAFT18BK-SF2025-11-11
00822383033235AeroFly transport Chair, 18", GrayAFT18GY-SF2025-11-11
00822383030333DriveCFPC17FS2025-09-03
00822383000190Drive35BWBE-FM-SC0535BWBE-FM-SC052025-09-02
00822383000206Drive35MCBE-B-SC0535MCBE-B-SC052025-09-02
00822383000213Drive35MCBE-A-SC0535MCBE-A-SC052025-09-02
00822383000220Drive35MCBE-FM-SC0535MCBE-FM-SC052025-09-02
00822383000237Drive42BWBE-B-SC0542BWBE-B-SC052025-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815067013098ProbasicsCOMPASS HEALTH BRANDS CORP.IMM2025-07-21
80193489142074MEDLINEMEDLINE INDUSTRIES, INC.IMM2025-03-10
80197344030001MEDLINEMEDLINE INDUSTRIES, INC.IMM2025-03-10
10810113576890Vive MobilityVIVE HEALTH LLCIMM2024-09-04
10810041984613ViveVIVE HEALTH LLCIMM2024-09-03
00841447114970HEMI SMT ART LGRST COMP FTPLT FOR 16-24WINVACARE CORPORATIONIMM2024-07-25
00841447114987EC HEMI ELEV LGRST NO-PAD CLF COMP FTPLTINVACARE CORPORATIONIMM2024-07-25
00841447114994HEMI SMART LEG ART.LEGS-ALUMINVACARE CORPORATIONIMM2024-07-25
80193489019314MedlineMEDLINE INDUSTRIES, INC.IMM2024-06-14
10193489019346MedlineMEDLINE INDUSTRIES, INC.IMM2024-03-05
00092237600504Roscoe MedicalCOMPASS HEALTH BRANDS CORP.IMM2024-02-28
07540147002213Maxx Adjustable Independent Footplates Motion Concepts IncIMM2023-10-04
00092237624197ProBasicsCOMPASS HEALTH BRANDS CORP.IMM2023-07-25
07540147002978Independent Legrest ReceiversMotion Concepts IncIMM2023-01-04
07540147002985Center Mount Legrest Hanger KitsMotion Concepts IncIMM2023-01-04
07540147002152Individual Cast FootplatesMotion Concepts IncIMM2022-12-08
07540147002190Multi-Axis Optional Footplates Motion Concepts IncIMM2022-12-08
07540147002206Adjustable Angle Footplates Motion Concepts IncIMM2022-12-08
07540147002220Adjustable Angle (Cut Out) FootplatesMotion Concepts IncIMM2022-12-08
07540147002237Individual Footplate Assemblies Motion Concepts IncIMM2022-12-08
07540147002244Footplate Heel LoopsMotion Concepts IncIMM2022-12-08
07540147002251Footplate Heel CupMotion Concepts IncIMM2022-12-08
07540147002268Footplate Toe StrapsMotion Concepts IncIMM2022-12-08
07540147002275Basic (Rubber Coated) Foot Platform MountMotion Concepts IncIMM2022-12-08
07540147002282Standard Flip-Up Foot PlatformMotion Concepts IncIMM2022-12-08
07540147002299Latitude Style Foot PlatformMotion Concepts IncIMM2022-12-08
07540147002800CM Legrest, Flip-Up Platform MountMotion Concepts IncIMM2022-12-08
07540147002817Maxx Power Down CM, Foot Platform MountMotion Concepts IncIMM2022-12-08
07540147002824CM Legrest, Multi-Axis Independent Footplate MountMotion Concepts IncIMM2022-12-08
07540147002831CM Legrest, Independent Footplate MountMotion Concepts IncIMM2022-12-08