LEG-UP

Basic Information

• Brand Name: LEG-UP
• Primary DI: 05050962080065
• Version / Model: LEG-UP YELLOW 26IN
• Catalog Number: HA0965
• Company Name: THE HELPING HAND COMPANY (LEDBURY) LIMITED
• Labeler DUNS: 397307240
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-02
• Public Version: 1
• Public Version Date: 2024-02-12
• Public Version Status: New
• Public Device Record Key: 1716c215-8208-456a-a91b-8fb7eb00ca86

Device Description

LEG-UP

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: 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
ILD	Adaptor, Dressing	Physical Medicine	890.5050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63227	Movement-resistance gait rehabilitation device	A collection of wearable belts, vest, straps and pulleys designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) with regaining lost motor function for ambulation using movement-resistant attachments to the legs/feet. This is a non-powered device intended to be used in the home.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05050962080065	GS1

Customer Contacts

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