FDA.reportPublic FDA data

Setmark Incorporated

Primary DI
00854204008061
Brand
Setmark Incorporated
Company
SETMARK INC.
Model
WC-102
Device description
"Wheelchair Stainless Steel, 20"" width x 16"" depth, flip up arm, dark blue vinyl#125, 300lb. capacity,"
Published
2018-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

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
K973418000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973418000UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4)Assembly Required Dist., Inc.1997-10-09IOR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854204008061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854204008061008542040080618542040080610854204008061

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, attendant/occupant-driven, rear-wheels-operated, 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 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
080798558
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854204008450Setmark Inc.ST-1032026-02-27
00854204008146SetmarkSS-1002024-10-15
00854204008153SetmarkSS-1012024-10-15
00854204008160SetmarkSS-1022024-10-15
00854204008177SetmarkSS-1032024-10-15
00854204008184SetmarkSS-1042024-10-15
00854204008191SetmarkSS-1052024-10-15
00854204008306SetmarkDC-1002024-10-15
00854204008313SetmarkDC-1012024-10-15
00854204008320SetmarkDC-1022024-10-15
00854204008337SetmarkDC-1032024-10-15
00854204008344SetmarkDC-1042024-10-15
00854204008603Setmark Inc.DC-1082024-04-21
00865388000482Setmark IncorporatedWA-1752018-01-31
00865388000499Setmark IncorporatedWA-1762018-01-31
00854204008030Setmark IncorporatedTR-1352018-01-31
00854204008597Setmark Inc.NF300/6277102020-03-23
00854204008047Setmark IncorporatedTR-1362018-01-31
00854204008054Setmark IncorporatedWC-1012018-01-31
00854204008078Setmark IncorporatedWC-1042018-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00810178884865Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885008Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885961Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885978Vive MobilityVIVE HEALTH LLCIOR2026-04-26
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
M36867322030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867322050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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
M36867342250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868262050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868262250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868282050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868282250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868302050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31