Probasics

GUDID 00815067012794

K3 LITE WHEELCHAIR, 18X16 W/ ELR, FLIP BACK HEIGHT ADJ DESK ARMS / CP: 1

COMPASS HEALTH BRANDS CORP.

Push-rim manual wheelchair, non-bariatric

• Primary Device ID: 00815067012794
• NIH Device Record Key: 544b3377-9ed2-4d43-b42c-2b0f89423b1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Probasics
• Version Model Number: WC3L1816DE
• Company DUNS: 827221698
• Company Name: COMPASS HEALTH BRANDS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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: true

Customer Support Contacts

• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815067012794 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112816

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: 4
• Public Version Date: 2024-05-01
• Device Publish Date: 2023-05-17

On-Brand Devices [Probasics]

• 00815067077021: PROBASICS BARIATRIC TRAPEZE - WT CAP 1,000 LBS (LEGS)
• 00815067072910: PB6074RW
• 00815067072903: PB6074BL
• 00815067072804: PROBASICS BARIATRIC TRAPEZE - WT CAP 1,000 LBS (UPPER COMPONENTS)
• 00815067072798: PROBASICS HYDRAULIC PATIENT LIFT - WT CAP 450 LBS
• 00815067072781: Full Electric Bed 36 X 80, Springs, Motor, Hi/Low Shaft
• 00815067072774: Full Electric Bed 36 X 80, Bed Ends & Casters
• 00815067077762: Full Electric Bed 36 X 80, LOW Bed Ends & Casters
• 00815067078417: 3-Motor Full Electric Bed 36 X 80, Bed Ends & Casters
• 00815067078400: 3-Motor Full Electric Bed 36 X 80, Springs & Motors
• 00815067072835: PROBASICS HYDRAULIC PATIENT LIFT - WT CAP 450 LBS
• 00815067078622: 3-Motor Full Electric Bed 36 X 80, Head Springs & Bed ends, Standard & Low Height
• 00815067078615: 3-Motor Full Electric Bed 36 X 80, Foot Springs/End - Standard & Low height
• 00815067072675: PROBASICS IV POLE 4 LEG 2 HOOK
• 00815067071579: PROBASICS 42" BARIATRIC BED - BED ENDS (3/3)
• 00815067071562: PROBASICS 42" BARIATRIC BED - FOOT SPRING (2/3)
• 00815067071555: PROBASICS 42" BARIATRIC BED - HEAD SPRING (1/3)
• 00815067078721: FOLDING 3-IN-1 COMMODE-SINGLE
• 00815067071890: BARIATRIC COMMODE - 24 " WIDE
• 00815067071852: BARIATRIC 3-IN-1 COMMODE
• 00815067071845: FOLDING 3-IN-1 COMMODE
• 00815067071838: 3-IN-1 COMMODE
• 00815067072019: RAISED TOILET SEAT WITH LOCK & ARMS
• 00815067072002: RAISED TOILET SEAT WITH LOCK
• 00815067071999: RAISED TOILET SEAT
• 00815067071906: DROP ARM COMMODE
• 00815067071869: BARIATRIC DROP ARM COMMODE
• 00815067071821: TOILET SAFETY FRAME
• 00815067072040: ROUND ADJUSTABLE SHOWER STOOL
• 00815067071951: SHOWER CHAIR WITH BACK & ARMS
• 00815067071944: BARIATRIC SHOWER CHAIR W/O BACK
• 00815067071937: BARIATRIC SHOWER CHAIR WITH BACK
• 00815067071920: SHOWER CHAIR, NO BACK
• 00815067071913: SHOWER CHAIR WITH BACK
• 30815067072034: CHROME KNURLED GRAB BAR-18"
• 30815067072027: CHROME KNURLED GRAB BAR-16"
• 30815067071983: PADDED TRANSFER BENCH KD
• 00815067071975: BARIATRIC TRANSFER BENCH
• 30815067071969: TRANSFER BENCH KD
• 00815067079025: GROUP 1 FOAM MATTRESS
• 00815067071302: Half Length Bed Rails
• 00815067080342: K3 LITE WHEELCHAIR, 20X16 W/ ELR, FLIP BACK HEIGHT ADJ DESK ARMS / CP: 1
• 00815067080335: K3 LITE WHEELCHAIR, 20X16 W/ SAFR, FLIP BACK HEIGHT ADJ DESK ARMS / CP: 1
• 00815067080328: K3 LITE WHEELCHAIR, 18X16 W/ ELR, FLIP BACK HEIGHT ADJ DESK ARMS / CP: 1
• 00815067080311: K3 LITE WHEELCHAIR, 18X16 W/ SAFR, FLIP BACK HEIGHT ADJ DESK ARMS / CP: 1
• 00815067080304: K3 LITE WHEELCHAIR, 16X16 W/ ELR, FLIP BACK HEIGHT ADJ DESK ARMS / CP: 1
• 00815067080298: K3 LITE WHEELCHAIR, 16X16 W/ SAFR, FLIP BACK HEIGHT ADJ DESK ARMS / CP: 1
• 00815067078516: ProBasics K4 Lite Wheelchair 16"x16" Height Adjustable, Flip Back, Desk-Length, Swing-Away Footr
• 00815067070923: ProBasics Reclining Manual Wheelchair, Removable 22"X 17", Desk-Length, Elevating Legrests
• 00815067070916: ProBasics Reclining Manual Wheelchair, Removable 20"X 17", Desk-Length, Elevating Legrests