Setmark Incorporated

GUDID 00854204008405

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

SETMARK INC.

Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

• Primary Device ID: 00854204008405
• NIH Device Record Key: 8390e6e2-bebe-4f29-ae31-dd8864f38fb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Setmark Incorporated
• Version Model Number: NF-102
• Company DUNS: 080798558
• Company Name: SETMARK INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854204008405 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973418

FDA Product Code

• IOR: Wheelchair, Mechanical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-31

On-Brand Devices [Setmark Incorporated]

• 00865388000499: L/R - PR to fit 26' width wheelchairs - w/ padded dark blue calf pad
• 00865388000482: L/R - PR to fit 18' thru 24' width wheelchairs - w/ padded dark blue calf pad
• 00865388000475: Wheelchair -Stainless Steel - 22" width x 18" depth, flip up arm, dark blue#125,
• 00865388000468: Hydraulic Stretcher, two tone color Blue and Gray base. Stretcher includes O2 tank, IV Pole,
• 00865388000451: Aluminum Stretcher, cut style frame with casters, less pad w/ Medical grade plastic top 500lb ca
• 00865388000444: Aluminum Stretcher w/5' casters w/ Medical grade plastic top
• 00865388000420: Stainless Steel Stretcher w/ 4 5' locking casters/fold down rails
• 00854204008429: Alum W/C 24' x 20', 500lb cap, non-foldable frame, dk blue
• 00854204008412: Alum W/C 20' seat width, dark blue uph. flip up armrests,alum. side panel , w/ footrests, 300l
• 00854204008405: Wheelchair, Alum. 22' seat width, 16' seat depth, 350lb cap., flip up arms, Dark Blue Vinyl, S/
• 00854204008245: Aluminum O2 tank holder only, 'E' tanks for WC
• 00854204008238: Aluminum I.V. pole for W/C, adjustable height, 2 hook, for WC -
• 00854204008221: Alumium O2 tank holder/IV pole, universal mount, adjustable height, 'E' tanks for WC
• 00854204008214: I.V. pole for W/C, adjustable height, 2 hook
• 00854204008207: O2 tank holder/IV pole, universal mount, adjustable height, 'E' tanks
• 00854204008139: Non-folding stainless steel WC, 24" x 20" Cap. Weight 600 lbs
• 00854204008122: Non-folding stainless steel WC, 22" x 20" Cap. Weight 600 lbs
• 00854204008115: Wheelchair stainless steel, 26" width x 20" depth, flip up arm, dark blue#125, 550lb. capacity,
• 00854204008108: Wheelchair stainless steel, 24" width x 20" depth, flip up arm, dark blue#125, 550lb. capacity,
• 00854204008092: Transport chair, stainless steel, 20" seat width -12-1/2" rear wheels, 300lb. capacity.Dark Blue
• 00854204008085: Transport chair, stainless steel, 18" seat width - 4 - 8" casters, 250lb. capacity.Dark Blue,
• 00854204008078: Wheelchair -Stainless Steel - 24" width x 18" depth, flip up arm, dark blue#125,
• 00854204008061: Wheelchair Stainless Steel, 20" width x 16" depth, flip up arm, dark blue vinyl#125, 300lb. cap
• 00854204008054: All Stainless Steel W/C, 18' width, removable full length arm, fixed footrest, dark blue#125,
• 00854204008047: Bariatric Walker: adj height: 32" - 38-1/2"
• 00854204008030: Walker: adj height: 32"-36" Dark Blue