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

Stretcher, Wheeled (FPO) (4) Accessories, Wheelchair (KNO) (2) Wheelchair, Mechanical (IOR) (1)

Premarket Exempt

No Yes

Clear

Setmark Incorporated - 00865388000420 Catalog Number :

Device Description : Stainless Steel Stretcher w/ 4 5' locking casters/fold down rails

Device Class : 2

Duns Number: 080798558

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

Setmark Incorporated - 00865388000444 Catalog Number :

Device Description : Aluminum Stretcher w/5' casters w/ Medical grade plastic top

Device Class : 2

Duns Number: 080798558

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

Setmark Incorporated - 00865388000451 Catalog Number :

Device Description : Aluminum Stretcher, cut style frame with casters, less pad w/ Medical grade plas Aluminum Stretcher, cut style frame with casters, less pad w/ Medical grade plastic top 500lb capacity

Device Class : 2

Duns Number: 080798558

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

Setmark Incorporated - 00865388000468 Catalog Number :

Device Description : Hydraulic Stretcher, two tone color Blue and Gray base. Stretcher includes O2 ta Hydraulic Stretcher, two tone color Blue and Gray base. Stretcher includes O2 tank, IV Pole,

Device Class : 2

Duns Number: 080798558

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

Setmark Incorporated - 00865388000475 Catalog Number :

Device Description : Wheelchair -Stainless Steel - 22" 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 - 00865388000482 Catalog Number :

Device Description : L/R - PR to fit 18' thru 24' width wheelchairs - w/ padded dark blue calf pad

Device Class : 1

Duns Number: 080798558

Premarket Exempt : Yes

Product Code : KNO

Prescription Use : No

Device Count : 1

Setmark Incorporated - 00865388000499 Catalog Number :

Device Description : L/R - PR to fit 26' width wheelchairs - w/ padded dark blue calf pad

Device Class : 1

Duns Number: 080798558

Premarket Exempt : Yes

Product Code : KNO

Prescription Use : No

Device Count : 1

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