FDA.reportPublic FDA data

Drive

Primary DI
00822384002056
Brand
Drive
Company
Drive Devilbiss Healthcare
Model
WCA806918BLK
Device description
Part Transport chairs/Wheelchairs Parts Product Description Calf Pads, blk, 1/ea
Published
2019-06-21
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
KNOACCESSORIES, WHEELCHAIR

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082784000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082784000JUMAO MANUAL WHEELCHAIRDanyang Jumao Healthcare Equipment Co., Ltd.2008-10-07IOR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822384002056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822384002056008223840020568223840020560822384002056

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
Premarket exempt
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00023601005168CAREX HEALTH BRANDSFGA51600 GRN2022-12-20
00023601005175CAREX HEALTH BRANDSFGA51700 BRNZ2022-12-20
00023601005182CAREX HEALTH BRANDSFGA51800 GRAY2022-12-20
00023601007117CAREX HEALTH BRANDSFGA71100 00002023-03-15
00023601007179CAREX HEALTH BRANDSFGA71700 00002023-03-15
00023601007186CAREX HEALTH BRANDSFGA71800 00002023-03-15
00023601007193CAREX HEALTH BRANDSFGA71900 00002023-03-15
00023601012210Carex Health BrandsFGA22100 00002022-12-09
00023601012227CAREX HEALTH BRANDSFGA22200 00002022-12-12
00023601012234CAREX HEALTH BRANDSFGA22300 00002022-12-12
00023601012302CAREX HEALTH BRANDSFGA23000 00002022-12-12
00023601012319CAREX HEALTH BRANDSFGA23177 00002022-12-12
00023601012333CAREX HEALTH BRANDSFGA23300 00002022-12-12
00023601013330CAREX HEALTH BRANDSFGA33300 00002022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00761887005402PryorPRYOR PRODUCTSKNO2026-05-31
06975996304019Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304026Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304033Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304040Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304057Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
04034089093246Abduction block (Hercules Prime, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089097640crotch pad with magnetic lock (Hercules Prime)Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103334Back cushion, seat reducer (Swifty 3)Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103341Seat minimizer Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103358Seat width reducer Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103365Lateral trunk supports, swing-away, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103372Lateral head supports, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103402Frame padding Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103419Canopy Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103433Rain poncho Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103464Pneumatic wheels, set, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103471under seat storage bag Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103488under seat storage basket Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103495Lateral trunk supports, rigid, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103501Drum brake, set, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103648Chin support rehabThomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089104010Incontinence Seat Cover size LThomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
M36867262250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282230R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31