Karman Heatlhcare

GUDID 00810058400062

XO-101 18" Manual Push-Power Assist Stand Wheelchair

KARMAN HEALTHCARE INC.

Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible

• Primary Device ID: 00810058400062
• NIH Device Record Key: fa71a836-c393-49fd-8365-2636db94b077
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Karman Heatlhcare
• Version Model Number: XO-101
• Company DUNS: 878092667
• Company Name: KARMAN HEALTHCARE INC.
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810058400062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122562

FDA Product Code

• ITI: Wheelchair, Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-18
• Device Publish Date: 2020-08-10

Devices Manufactured by KARMAN HEALTHCARE INC.

• 00810058401588 - Karman Healthcare: 2024-07-08 Overbed Table, Adjustable Height
• 00810058400123 - Karman Healthcare: 2022-11-07 802-DY 18" seat Ultra Lightweight Wheelchair with Flip Back Armrest
• 00810058400130 - Karman Healthcare: 2022-11-07 802-DY 16" seat Ultra Lightweight Wheelchair with Flip Back Armrest
• 00810058400161 - Karman Healthcare: 2022-11-07 R-3600 3 Wheel Rollator with Large 8" Casters , Aluminum, 13lbs - Blue
• 00810058400178 - Karman Healthcare: 2022-11-07 R-3600 3 Wheel Rollator with Large 8" Caster , Aluminum, 13lbs - Burgundy
• 00810058400185 - Karman Healthcare: 2022-11-07 R-4600 Lightweight Standard Rollator with Padded Seat and Backrest in Blue
• 00810058400192 - Karman Healthcare: 2022-11-07 R-4600 Lightweight Standard Rollator with Padded Seat and Backrest in Burgundy
• 00810058400208 - Karman Healthcare: 2022-11-07 R-4700 Extra Wide Bariatric Rollator with Padded Flip-down Seat, Steel, 24 lbs.-Blue