FDA.reportPublic FDA data

Setmark Incorporated

Primary DI
00854204008030
Brand
Setmark Incorporated
Company
SETMARK INC.
Model
TR-135
Device description
"Walker: adj height: 32""-36"" 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
ITJWalker, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITJWalker, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854204008030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854204008030008542040080308542040080300854204008030

GMDN Terms#

Term, Definition table
TermDefinition
Basic walker, foldableAn all- or partially-wheeled mobility aid in the form of a waist-high, foldable framework with handgrips and four or three legs designed to provide a stable support to a person with a disability, a geriatric or an infirm person when standing or ambulating; it may also be used during rehabilitation. It is constructed of lightweight metal, plastic, and rubber materials and in the form of a mobile support structure which the user holds and pushes in front of them as they walk. It is foldable for storage and transportation, and includes a braking mechanism; it may be width-adjustable and some types may include a seat on which the user can rest.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080798558
Device count
1
Premarket exempt
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
00854204008597Setmark Inc.NF300/6277102020-03-23
00854204008047Setmark IncorporatedTR-1362018-01-31
00854204008054Setmark IncorporatedWC-1012018-01-31
00854204008061Setmark IncorporatedWC-1022018-01-31
00854204008078Setmark IncorporatedWC-1042018-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977176610248BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
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