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

Accessories, Wheelchair (KNO) (5) Wheelchair, Mechanical (IOR) (4) Stretcher, Wheeled (FPO) (1)

Premarket Exempt

Yes No

Clear

Setmark Incorporated - 00854204008139 Catalog Number :

Device Description : Non-folding stainless steel WC, 24" x 20" Cap. Weight 600 lbs

Device Class : 1

Duns Number: 080798558

Premarket Exempt : No

Product Code : IOR

Prescription Use : No

Device Count : 1

Setmark Incorporated - 00854204008207 Catalog Number :

Device Description : O2 tank holder/IV pole, universal mount, adjustable height, 'E' tanks

Device Class : 1

Duns Number: 080798558

Premarket Exempt : Yes

Product Code : KNO

Prescription Use : No

Device Count : 1

Setmark Incorporated - 00854204008214 Catalog Number :

Device Description : I.V. pole for W/C, adjustable height, 2 hook

Device Class : 1

Duns Number: 080798558

Premarket Exempt : Yes

Product Code : KNO

Prescription Use : No

Device Count : 1

Setmark Incorporated - 00854204008221 Catalog Number :

Device Description : Alumium O2 tank holder/IV pole, universal mount, adjustable height, 'E' tanks for WC

Device Class : 1

Duns Number: 080798558

Premarket Exempt : Yes

Product Code : KNO

Prescription Use : No

Device Count : 1

Setmark Incorporated - 00854204008238 Catalog Number :

Device Description : Aluminum I.V. pole for W/C, adjustable height, 2 hook, for WC -

Device Class : 1

Duns Number: 080798558

Premarket Exempt : Yes

Product Code : KNO

Prescription Use : No

Device Count : 1

Setmark Incorporated - 00854204008245 Catalog Number :

Device Description : Aluminum O2 tank holder only, 'E' tanks for WC

Device Class : 1

Duns Number: 080798558

Premarket Exempt : Yes

Product Code : KNO

Prescription Use : No

Device Count : 1

Setmark Incorporated - 00854204008405 Catalog Number :

Device Description : Wheelchair, Alum. 22' seat width, 16' seat depth, 350lb cap., flip up arms, Dar Wheelchair, Alum. 22' seat width, 16' seat depth, 350lb cap., flip up arms, Dark Blue Vinyl, S/A footrest

Device Class : 1

Duns Number: 080798558

Premarket Exempt : No

Product Code : IOR

Prescription Use : No

Device Count : 1

Setmark Incorporated - 00854204008412 Catalog Number :

Device Description : Alum W/C 20' seat width, dark blue uph. flip up armrests,alum. side panel , w/ Alum W/C 20' seat width, dark blue uph. flip up armrests,alum. side panel , w/ footrests, 300lb capacity

Device Class : 1

Duns Number: 080798558

Premarket Exempt : No

Product Code : IOR

Prescription Use : No

Device Count : 1

Setmark Incorporated - 00854204008429 Catalog Number :

Device Description : Alum W/C 24' x 20', 500lb cap, non-foldable frame, dk blue

Device Class : 1

Duns Number: 080798558

Premarket Exempt : No

Product Code : IOR

Prescription Use : No

Device Count : 1

Setmark Inc. - 00854204008597 Catalog Number :

Device Description : Cut - off Hydraulic stretcher, includes O2 tank & IV pole - Non Ferrous.NF-300

Device Class : 2

Duns Number: 080798558

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

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