Karman Healthcare

Basic Information

• Brand Name: Karman Healthcare
• Primary DI: 00810058400079
• Version / Model: XO-101N
• Company Name: KARMAN HEALTHCARE INC.
• Labeler DUNS: 878092667
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-10
• Public Version: 1
• Public Version Date: 2020-08-18
• Public Version Status: New
• Public Device Record Key: 63acc28a-5cd2-405e-92ae-ecce179bc82a

Device Description

XO-101 16" Manual Push-Power Assist Stand Wheelchair

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITI	Wheelchair, Powered	Physical Medicine	890.3860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41877	Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible	A wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be propelled by power from one or more electric motor(s). The electronic control of speed and direction are performed by the occupant of the device. The device cannot be folded or readily dismantled for transport.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810058400079	GS1

Premarket Submissions

Submission Number	Supplement Number
K122562	000