FDA.reportPublic FDA data

Drive

Primary DI
00822383227320
Brand
Drive
Company
Drive Devilbiss Healthcare
Model
STD28ECDDA-ELR
Device description
Transport/WheelchairWheelchairs K6 Product Description: SentraEC,28"HD.DetDskArm,ElvLg 1/cs
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
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IORWheelchair, mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IORWheelchair, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822383227320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383227320008223832273208223832273200822383227320

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
false
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
00840363375540KiKI MOBILITY, LLCIOR2026-03-11
00810178884506ViveVIVE HEALTH LLCIOR2026-03-06
00810178885213ViveVIVE HEALTH LLCIOR2026-03-06
00810178885220ViveVIVE HEALTH LLCIOR2026-03-06
00810178885237ViveVIVE HEALTH LLCIOR2026-03-06
00840117408661ConvaidCONVAID PRODUCTS, INC.IOR2026-03-05
00840117408678ConvaidCONVAID PRODUCTS, INC.IOR2026-03-05
00840117408685ConvaidCONVAID PRODUCTS, INC.IOR2026-03-05
00840117408692ConvaidCONVAID PRODUCTS, INC.IOR2026-03-05
00840117408708ConvaidCONVAID PRODUCTS, INC.IOR2026-03-05
00840117408715ConvaidCONVAID PRODUCTS, INC.IOR2026-03-05
00840117408722ConvaidCONVAID PRODUCTS, INC.IOR2026-03-05
04719873857104KarmaKARMA MOBILITY COMPANY LIMITEDIOR2026-02-25
04719873857395KarmaKARMA MOBILITY COMPANY LIMITEDIOR2026-02-25
00841447116301Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116318Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116325Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116332Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116349Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116356Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116363Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116370Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116387Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116394Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116400Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116417Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00840117408180ConvaidCONVAID PRODUCTS, INC.IOR2026-02-05
00840117408197ConvaidCONVAID PRODUCTS, INC.IOR2026-02-05
00840117408203ConvaidCONVAID PRODUCTS, INC.IOR2026-02-05
00840117408210ConvaidCONVAID PRODUCTS, INC.IOR2026-02-05