Levity

Basic Information

• Brand Name: Levity
• Primary DI: 00628719745014
• Version / Model: LVHP-0100
• Catalog Number: LVHP-0100
• Company Name: Ora Médical Inc
• Labeler DUNS: 243259001
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-22
• Public Version: 1
• Public Version Date: 2024-12-02
• Public Version Status: New
• Public Device Record Key: 2a0eb0f7-dea4-42bc-989c-ded1317ef389

Device Description

HealthCare Professional Kit

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: 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
ITJ	Walker, Mechanical	Physical Medicine	890.3825	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66307	Hands-free disability-assistive walker	A non-powered wheeled mobility aid in the form of a non-foldable framework with legs designed to provide a stable hands-free support for a patient with a walking disability (e.g., due to cerebral palsy) or a geriatric/infirm patient when standing or ambulating. It is made of sturdy but lightweight materials in the shape of a mobile support structure with a rear-support mechanism which provides weight-bearing from the back of the patient (e.g., straps around the back and abdominopelvic area).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00628719745014	GS1