EasyStand

Basic Information

• Brand Name: EasyStand
• Primary DI: 10858921006031
• Version / Model: Evolv Large Glider
• Company Name: ALTIMATE MEDICAL INC.
• Labeler DUNS: 148515216
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 4
• Public Version Date: 2022-08-05
• Public Version Status: Update
• Public Device Record Key: 890ea61d-ab89-4ac0-bdf2-c30121f52154

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: 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
INO	Chair, Positioning, Electric	Physical Medicine	890.3110	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61704	Manual stander/exerciser	A manually-powered device designed to support and lift a disabled (paraplegic) patient to an upright standing position, and to enable the occupant to perform an exercise, to provide the health benefits associated with standing/exercising; it is neither intended to facilitate gait, provide patient mobility, nor assist standing transfer. It typically consists of a seat and/or platform with appropriate supports (e.g., footplates, kneepads, chest pad), an exercise mechanism (e.g., moveable handles with reciprocal leg movement), and a manual mechanical lifting mechanism; the patient is raised from a supine and/or seated position by themselves or with the assistance of a healthcare provider.	No	Active
61703	Electric stander/exerciser	An electrically-powered device designed to support and lift a disabled (paraplegic) patient to an upright standing position, and to enable the occupant to perform an exercise, to provide the health benefits associated with standing/exercising; it is neither intended to facilitate gait, provide patient mobility, nor assist standing transfer. It typically consists of a seat and/or platform with appropriate supports (e.g., footplates, kneepads, chest pad), an exercise mechanism (e.g., moveable handles with reciprocal leg movement) and an electrically-powered lifting mechanism to raise the patient from a supine and/or seated position to standing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10858921006031	GS1

Premarket Submissions

Submission Number	Supplement Number
K062402	000