DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756677776
• Version / Model: M5165
• Catalog Number: M5165
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-03
• Public Version: 1
• Public Version Date: 2021-08-11
• Public Version Status: New
• Public Device Record Key: 8fb31c7e-82b5-46f0-83c5-8d807bef65d6

Device Description

Gait Belt, Heavy Duty

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IKX	AID, TRANSFER	Physical Medicine	890.5050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58876	Gait rehabilitation system harness	A lifting device, in the form of belts and straps, which is a component of a gait rehabilitation system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function. The device is designed to be secured around the patient?s upper body and hips and is intended to help suspend the patient vertically over the floor or a treadmill while attached to the supporting frame of a suspension device; it may be used in conjunction with a robotic orthosis device for the training of normal gait.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00749756677776	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]