STANDY

Basic Information

• Brand Name: STANDY
• Primary DI: 08055715705094
• Version / Model: STANDY-4 large
• Company Name: ORMESA SRL
• Labeler DUNS: 432070019
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-31
• Public Version: 1
• Public Version Date: 2025-02-10
• Public Version Status: New
• Public Device Record Key: 0f9b5a8d-08a6-45bf-b52c-94b8c68272c1

Device Description

Vertical standing frame for the acquisition and maintenance of an upright position and the training of the antigravity muscles of young, adult or elderly who cannot acquire and maintain them independently. Indicated for persons with functional deficits in verticalization and in maintaining an upright position, who have a minimum residual control of the trunk and head; users suffering from pathologies with alteration and impairment of the residual postural control, in which the load on the lower limbs is allowed, to improve bone density, ventilatory capacity, intestinal peristalsis, bladder function, blood circulation.

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: Yes
• Has Serial Number: No
• 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
INM	Chair, With Casters	Physical Medicine	890.3100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61700	Manual stander	A manually-powered, mobile device designed to support and lift a disabled (paraplegic) patient to an upright standing position to provide the health benefits associated with standing (e.g., improved breathing, circulation, and flexibility); it is neither intended to facilitate gait nor assist standing transfer. It typically consists of a seat, sling and/or platform with appropriate supports (e.g., footplates, kneepads, chest pad), wheels, and a manual mechanical lifting mechanism whereby the patient is raised from a supine, prone, and/or seated position by themselves or with the assistance of a healthcare provider. It includes wheels for reorientation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08055715705094	GS1