FDA.reportPublic FDA data

MEDLINE

Primary DI
00197344159874
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
K1186V22ESH
Catalog number
K1186V22ESH
Device description
"WC,K1,VINYL,18"",SB DLA,ELR, SH BRANDED"
Published
2025-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IORWheelchair, mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IORWheelchair, MechanicalPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232230000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232230000YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE)Zhenjiang Assure Medical Equipment Co., Ltd.2023-10-03IOR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197344159874PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197344159874001973441598741973441598740197344159874

GMDN Terms#

Term, Definition table
TermDefinition
Push-rim manual wheelchair, non-bariatricA non-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize by pushing specially designed rims on the wheels while seated. It is designed with a pair of larger wheels with push-rims attached whereby the occupant propels the device by rotating both wheels; it typically includes rear-fitted handles designed for optional pushing by an attendant. It provides no function outside of wheeled mobilization.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197344039791MEDLINEHNX22075HNX220752024-10-11
10197344039807MEDLINEHNX22100HNX221002024-10-11
10888277348226MEDLINEMDS630S2MDS630S22026-07-29
10888277699472MEDLINEDYND300010SDYND300010S2026-07-29
10888277699489MEDLINEDYND300015SDYND300015S2026-07-29
10888277699496MEDLINEDYND300020SDYND300020S2026-07-29
10888277699502MEDLINEDYND300025SDYND300025S2026-07-29
10888277699533MEDLINEDYND300050SDYND300050S2026-07-29
10888277701588MEDLINEMSC9912EPMSC9912EP2025-09-24
10888277701595MEDLINEMSC9918EPMSC9918EP2025-09-24
10888277701618MEDLINEMSC9945EPMSC9945EP2025-09-24
10888277701625MEDLINEMSC9948EPMSC9948EP2025-09-24
10888277701632MEDLINEMSC9966EPMSC9966EP2025-09-24
10888277701649MEDLINEMSC99812EPMSC99812EP2025-09-24
30193489103964MEDLINE1202YLW3AOS2026-07-28
30193489103971MEDLINE1202YLW3XL2026-07-28
10197344216123MEDLINESSBCS21GLSSBCS21GL2026-07-24
10197344219575MEDLINEMDS99905MDS999052026-07-24
10653160391326MEDLINEEBSI1865EBSI18652026-07-24
30193489017742MEDLINE6651CBL22X16651CBL22X12026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719876192295TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.IOR2026-07-09
04719876191953TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.IOR2026-07-08
04719876192318TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.IOR2026-07-08
00822383037127Silver SportDrive Devilbiss HealthcareIOR2026-06-22
00822383037134Silver SportDrive Devilbiss HealthcareIOR2026-06-22
00822383037141Silver SportDrive Devilbiss HealthcareIOR2026-06-22
00822383037158Cruiser 3 16"Drive Devilbiss HealthcareIOR2026-06-22
00822383037165Cruiser 3 18"Drive Devilbiss HealthcareIOR2026-06-22
00822383037172Cruiser 3 20"Drive Devilbiss HealthcareIOR2026-06-22
06970006394691DAYANG MEDICALGuangdong Dayang Medical Technology Co.,LtdIOR2026-06-10
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
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
M36867302230R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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M36867322250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867342030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867342050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867342230R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31