SETMARK INC.

Address:1712 Pioneer Ave Suite 764,Cheyenne,WY,82001,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Wheelchair, Mechanical (IOR) (8) Walker, Mechanical (ITJ) (2)

Premarket Exempt

No Yes

Clear

Setmark Incorporated - 00854204008030 Catalog Number :

Device Description : Walker: adj height: 32"-36" Dark Blue

Device Class : 1

Duns Number: 080798558

Premarket Exempt : Yes

Product Code : ITJ

Prescription Use : No

Device Count : 1

Setmark Incorporated - 00854204008047 Catalog Number :

Device Description : Bariatric Walker: adj height: 32" - 38-1/2"

Device Class : 1

Duns Number: 080798558

Premarket Exempt : Yes

Product Code : ITJ

Prescription Use : No

Device Count : 1

Setmark Incorporated - 00854204008054 Catalog Number :

Device Description : All Stainless Steel W/C, 18' width, removable full length arm, fixed footrest, All Stainless Steel W/C, 18' width, removable full length arm, fixed footrest, dark blue#125, rem. front rigging -

Device Class : 1

Duns Number: 080798558

Premarket Exempt : No

Product Code : IOR

Prescription Use : No

Device Count : 1

Setmark Incorporated - 00854204008061 Catalog Number :

Device Description : Wheelchair Stainless Steel, 20" width x 16" depth, flip up arm, dark blue vinyl Wheelchair Stainless Steel, 20" width x 16" depth, flip up arm, dark blue vinyl#125, 300lb. capacity,

Device Class : 1

Duns Number: 080798558

Premarket Exempt : No

Product Code : IOR

Prescription Use : No

Device Count : 1

Setmark Incorporated - 00854204008078 Catalog Number :

Device Description : Wheelchair -Stainless Steel - 24" width x 18" depth, flip up arm, dark blue#125,

Device Class : 1

Duns Number: 080798558

Premarket Exempt : No

Product Code : IOR

Prescription Use : No

Device Count : 1

Setmark Incorporated - 00854204008085 Catalog Number :

Device Description : Transport chair, stainless steel, 18" seat width - 4 - 8" casters, 250lb. capaci Transport chair, stainless steel, 18" seat width - 4 - 8" casters, 250lb. capacity.Dark Blue,

Device Class : 1

Duns Number: 080798558

Premarket Exempt : No

Product Code : IOR

Prescription Use : No

Device Count : 1

Setmark Incorporated - 00854204008092 Catalog Number :

Device Description : Transport chair, stainless steel, 20" seat width -12-1/2" rear wheels, 300lb. ca Transport chair, stainless steel, 20" seat width -12-1/2" rear wheels, 300lb. capacity.Dark Blue,

Device Class : 1

Duns Number: 080798558

Premarket Exempt : No

Product Code : IOR

Prescription Use : No

Device Count : 1

Setmark Incorporated - 00854204008108 Catalog Number :

Device Description : Wheelchair stainless steel, 24" width x 20" depth, flip up arm, dark blue#125, 5 Wheelchair stainless steel, 24" width x 20" depth, flip up arm, dark blue#125, 550lb. capacity,

Device Class : 1

Duns Number: 080798558

Premarket Exempt : No

Product Code : IOR

Prescription Use : No

Device Count : 1

Setmark Incorporated - 00854204008115 Catalog Number :

Device Description : Wheelchair stainless steel, 26" width x 20" depth, flip up arm, dark blue#125, 5 Wheelchair stainless steel, 26" width x 20" depth, flip up arm, dark blue#125, 550lb. capacity,

Device Class : 1

Duns Number: 080798558

Premarket Exempt : No

Product Code : IOR

Prescription Use : No

Device Count : 1

Setmark Incorporated - 00854204008122 Catalog Number :

Device Description : Non-folding stainless steel WC, 22" x 20" Cap. Weight 600 lbs

Device Class : 1

Duns Number: 080798558

Premarket Exempt : No

Product Code : IOR

Prescription Use : No

Device Count : 1

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