FDA.reportPublic FDA data

Setmark Incorporated

Primary DI
00854204008085
Brand
Setmark Incorporated
Company
SETMARK INC.
Model
WC-115
Device description
"Transport chair, stainless steel, 18"" seat width - 4 - 8"" casters, 250lb. capacity.Dark Blue,"
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
00854204008085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854204008085008542040080858542040080850854204008085

GMDN Terms#

Term, Definition table
TermDefinition
Transport wheelchair, collapsibleA wheeled personal mobility device designed for transporting persons (not bariatric) over a short distance and generally limited to indoor use or use outdoors over smooth paved surfaces. It has small wheels that the occupant cannot use for propulsion and incorporates a simple seat-support system for a person with a disability or a person without the full capacity to walk. It will also include footrests to keep the occupant's feet raised from the ground. It is typically used in hospitals, institutions, airports, and railway stations. Also known as a transportation chair or transit wheelchair, it 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
Donation ID 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
00854204008061Setmark IncorporatedWC-1022018-01-31

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
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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