FDA.reportPublic FDA data

Drive

Primary DI
00822383226187
Brand
Drive
Company
Drive Devilbiss Healthcare
Model
KA 1035 FPL
Device description
Nimbo Forearm Platfrm/MtgBrckt,Lg,1pr/bx
Published
2017-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00822383226187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383226187008223832261878223832261870822383226187

GMDN Terms#

Term, Definition table
TermDefinition
Forearm support crutchA staff-like mobility aid used to assist a person with a disability to support their weight while walking. The device has one or more legs and a padded support or "trough" in a horizontal position for the user to rest the forearm. The hand wraps around a grip at the end of the forearm support. The device may be adjustable in length and is typically made of metal [e.g., aluminium (Al), titanium (Ti)]. This device is particularly suited to individuals who cannot rest their weight on their hands.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
867673159
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00023601061102Carex Health BrandsFGR11000 00002016-10-07
00092237614419Roscoe MedicalHUM-ROS62018-12-19
50050428250391DRIVEMEDICAL7417372019-06-21
00311917192352Walgreens9847282019-06-21
00822383989815DRIVEMEDICAL146-RTLPC23201-M2019-06-21
00822383989839DRIVEMEDICAL146-RTLPC23201-F2019-06-21
00822383246420DriveRTLPC23201-F2017-05-19
00822383037127Silver SportBIN-SSP316DDA-SF2026-06-22
00822383037134Silver SportBIN-SSP218DDA-SF2026-06-22
00822383037141Silver SportBIN-SSP220DDA-SF2026-06-22
00822383037158Cruiser 3 16"BIN-K316ADDA-SF2026-06-22
00822383037165Cruiser 3 18"BIN-K318ADDA-SF2026-06-22
00822383037172Cruiser 3 20"BIN-K320ADDA-SF2026-06-22
00194346283439EquateEQKW5002026-06-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977176610248BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610255BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610262BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610279BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610286BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610293BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610309BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610316BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610323BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610330BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610347BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610354BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610361BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610378BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610385BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610392BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610408BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610415BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610422BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610439BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610446BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610453BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610460BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610477BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610484BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610491BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610507BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610514BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610521BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610538BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25