FDA.reportPublic FDA data

Drive

Primary DI
00822383289649
Brand
Drive
Company
Drive Devilbiss Healthcare
Model
DS-XLT20ADDASV-ELR
Device description
Transport/WheelchairWheelchairs K4 Product Description: PanaceaXLTLtWtWC,AdjFlipBkDesk,20iw/Elr
Published
2017-07-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IORWheelchair, mechanical
KNNCOMPONENTS, WHEELCHAIR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IORWheelchair, MechanicalPhysical Medicine1
KNNComponents, WheelchairPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930411000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930411000UNIVERSAL WHEELCHAIREverest & Jennings, Inc.1993-03-31IOR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822383289649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383289649008223832896498223832896490822383289649

GMDN Terms#

Term, Definition table
TermDefinition
Transport wheelchair, collapsibleA wheeled personal mobility device designed for transporting persons (not bariatric) over a short distance and generally limited to indoor use or use outdoors over smooth paved surfaces. It has small wheels that the occupant cannot use for propulsion and incorporates a simple seat-support system for a person with a disability or a person without the full capacity to walk. It will also include footrests to keep the occupant's feet raised from the ground. It is typically used in hospitals, institutions, airports, and railway stations. Also known as a transportation chair or transit wheelchair, it may be disassembled or folded for transport.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
867673159
Device count
1
Serial number
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
10858921006239LeggeroALTIMATE MEDICAL INC.IOR2026-08-18
09420082931091Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931107Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931114Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931121Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931138Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931145Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931152Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931169Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931176Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931183Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931190Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931206Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931213Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931220Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931237Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931244Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931251Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931268Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931275Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931282Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931299Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931305Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931312Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931329Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931336Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931343Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931350Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931367Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931374Spex LimitedSPEX LIMITEDKNN2026-07-31