FDA.reportPublic FDA data

NA

Primary DI
00842307102878
Brand
NA
Company
GENDRON, INC.
Model
6730-22-61-78-29-8
Device description
WHEELCHAIR,30X22DP,REM ARM,Q/R700 LB CAPACITY,REGENCY XL2000
Published
2017-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00842307102878PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842307102878008423071028788423071028780842307102878

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
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
false
Sterilization required before use
false

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
00884389150835MEDLINEMEDLINE INDUSTRIES, INC.INM2026-02-26
40884389150802MEDLINEMEDLINE INDUSTRIES, INC.INM2026-02-26
40884389150819MEDLINEMEDLINE INDUSTRIES, INC.INM2026-02-26
00840117408340ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408357ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408364ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408371ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408388ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408395ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408401ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408418ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408425ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408432ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408449ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408456ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408463ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408470ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408487ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408494ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408500ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408517ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408524ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408531ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408548ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408555ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408562ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408579ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00860006970789Med SledEthos Evacuation Strategies, LLCINM2026-01-27
06973717270773DahaoFoshan Dahao Medical Technology Co., Ltd.INM2026-01-22
00860014637803MaclarenCOCHE MOBILITY SOLUTIONS INC.INM2026-01-08