FDA.reportPublic FDA data

NA

Primary DI
00842307100270
Brand
NA
Company
GENDRON, INC.
Model
6728-20-62-78-29-8
Device description
WHEELCHAIR,28X20DP,REM ARM,Q/R 700 LB CAPACITY,REGENCY XL2000
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
INMChair, With Casters

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INMChair, With CastersPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842307100270PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842307100270008423071002708423071002700842307100270

GMDN Terms#

Term, Definition table
TermDefinition
Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsibleA wheeled personal mobility device that incorporates a heavy-duty framework and extra wide seat-support system for a bariatric (obese) person with a disability or an obese person without the full capacity to walk, and is manually propelled by the user while seated in the device or by an attendant. The occupant moves the device by rotating both rear wheels. An attendant moves the device by pushing or pulling handles on the device. The device may be disassembled or folded for transport.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
054164587
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842307100003NA1000MR-1242016-09-23
00842307100010NA1050-123-213-122-1512016-09-23
00842307100027NA11502016-09-23
00842307100034NA1150-123-213-1402016-09-23
00842307100041NA1190-1322016-09-23
00842307100058NA16002016-09-23
00842307100065NA3150-4043-62016-09-23
00842307100072NA3642HC2016-09-23
00842307100096NA36482016-09-23
00842307100102NA4000MRQ22016-09-23
00842307100119NA4748SB2016-09-23
00842307100126NA5154DX-12016-09-23
00842307100133NA5154PDX2016-09-23
00842307100140NA5322-18-62-36-P11882016-09-23
00842307100157NA5324-18-61-36-P11882016-09-23
00842307100164NA5424-18-61-36-P11882016-09-23
00842307100171NA6324-18-61-78-36-8-P11882016-09-23
00842307100188NA6424-18-61-78-36-8-P11882016-09-23
00842307100195NA6724-18-61-78-29-82016-09-23
00842307100201NA6724-18-62-78-28-82016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054040402135BUGORMESA SRLINM2026-08-01
08054040402142BUGORMESA SRLINM2026-08-01
08055715702949BUGORMESA SRLINM2026-08-01
08055715702956BUGORMESA SRLINM2026-08-01
08055715702963BUGORMESA SRLINM2026-08-01
08055715702970BUGORMESA SRLINM2026-08-01
08055715703021BUGORMESA SRLINM2026-08-01
08055715703038BUGORMESA SRLINM2026-08-01
08055715703045BUGORMESA SRLINM2026-08-01
08055715703052BUGORMESA SRLINM2026-08-01
08055715703106BUGORMESA SRLINM2026-08-01
08055715703113BUGORMESA SRLINM2026-08-01
08055715703120BUGORMESA SRLINM2026-08-01
08055715703137BUGORMESA SRLINM2026-08-01
08055715703182BUGORMESA SRLINM2026-08-01
08055715703199BUGORMESA SRLINM2026-08-01
08055715703205BUGORMESA SRLINM2026-08-01
08055715703212BUGORMESA SRLINM2026-08-01
06973717271602GARVEEFoshan Dahao Medical Technology Co., Ltd.INM2026-07-29
06973717271633GARVEEFoshan Dahao Medical Technology Co., Ltd.INM2026-07-29
06973717272104GARVEEFoshan Dahao Medical Technology Co., Ltd.INM2026-07-29
06973717276836GARVEEFoshan Dahao Medical Technology Co., Ltd.INM2026-07-29
06973717276843GARVEEFoshan Dahao Medical Technology Co., Ltd.INM2026-07-29
06973717276881GARVEEFoshan Dahao Medical Technology Co., Ltd.INM2026-07-29
06973717276829VerpalFoshan Dahao Medical Technology Co., Ltd.INM2026-06-06
00840117408739ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408746ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408753ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408760ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408777ConvaidCONVAID PRODUCTS, INC.INM2026-04-10