FDA.reportPublic FDA data

Drive

Primary DI
00822383004235
Brand
Drive
Company
Drive Devilbiss Healthcare
Model
R800KD-RD
Device description
Product Description KD Rollator, 6" 4Whl,Steel,Red,1/ea
Published
2020-05-27
Public version status
Update
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
00822383004235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383004235008223830042358223830042350822383004235

GMDN Terms#

Term, Definition table
TermDefinition
Disability-assistive walker, non-powered, foldableA non-powered, all- or partially-wheeled mobility aid in the form of a waist-high, foldable framework with handgrips and three or four legs designed to provide a stable support for a patient with a disability, a geriatric, obese, or infirm patient 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 patient holds and pushes in front of them as they walk. It is foldable for storage and transportation and may include a braking mechanism; it may be width-adjustable and some types may include a seat on which the patient can rest.

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
true
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
06975960550749noneZhejiang Mateside Medical Devices Technology Co., LtdITJ2026-05-25
06975960550701noneZhejiang Mateside Medical Devices Technology Co., LtdITJ2026-03-24
00810178887392Vive MobilityVIVE HEALTH LLCITJ2026-02-18
00860014768644RideNwalkINNOMOTIVE L.L.CITJ2026-02-04
00860014768651RideNwalkINNOMOTIVE L.L.CITJ2026-02-04
00810178883882Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178883899Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178885206Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178885497Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178885503Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178885510Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178887064Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178887071Vive MobilityVIVE HEALTH LLCITJ2026-02-03
04895262504016HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-01-26
00057475820213BIOS LivingThermor LtdITJ2026-01-19
06975960550602noneZhejiang Mateside Medical Devices Technology Co., LtdITJ2026-01-15
06975185620166BaichenNINGBO BAICHEN MEDICAL DEVICES CO., LTDITJ2026-01-07
06975960551470VOCICZhejiang Mateside Medical Devices Technology Co., LtdITJ2026-01-04
06975960551487VOCICZhejiang Mateside Medical Devices Technology Co., LtdITJ2026-01-04
06979196001167RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001174RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001181RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001198RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001204RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001211RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001228RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001235RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001242RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001259RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06975960551463VOCICZhejiang Mateside Medical Devices Technology Co., LtdITJ2025-12-03