Hi-Fortune

Basic Information

• Brand Name: Hi-Fortune
• Primary DI: 06973852590064
• Version / Model: HR-111-02
• Company Name: Kunshan Hi-Fortune Health Products Co.,Ltd
• Labeler DUNS: 548310008
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-23
• Public Version: 1
• Public Version Date: 2021-11-01
• Public Version Status: New
• Public Device Record Key: ff0e24b1-83ff-49ef-a8f8-c768de2c9794

Device Description

Weight: 7.8kg, L570mm*W390mm*H985mm

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
KNL	Board, Scooter, Prone	Physical Medicine	890.5370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31144	Assistive scooter, foot-propelled	A mobility device with two main wheels attached to a footboard (sometimes with stabilizing wheels at the rear) and a steering handle directly connected to the front wheel, that is designed to be operated by a person with a disability who propels the device by pushing on the ground with one foot while standing on the footboard with the other. This device is used to enhance the user's ability for self-transportation in the local environment and/or to promote the user's physical/recreational activities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06973852590064	GS1