Karman Healthcare

Basic Information

• Brand Name: Karman Healthcare
• Primary DI: 00859706005976
• Version / Model: XO-55N
• 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: a769a33a-b8b6-4fe8-a15c-b08cd7fcdd4b

Device Description

XO-55 Horizon series 16" Seat Manual Propel Manual Stand

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
IPL	Wheelchair, Standup	Physical Medicine	890.3900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41620	Wheelchair, attendant/occupant-driven, rear-wheels-operated, 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 manually propelled by the user while seated in the device or by an attendant. The occupant moves the device by rotating both rear wheels. An attendant moves the device by pushing or pulling handles on 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	00859706005976	GS1

Premarket Submissions

Submission Number	Supplement Number
K122562	000