JUDITTA

Basic Information

• Brand Name: JUDITTA
• Primary DI: 08055715702291
• Version / Model: JUDITTA-40 B60 LIGHT GREY, BLACK FRAME, WITH MANUAL BRAKES FOR THE CARE GIVER
• 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: f8c7be88-ba67-409d-a657-2772b30061e2

Device Description

Tilting seating system intended for users with significant systemic, neurological, orthopedic impairment; patients with reduced or no degree of mobility, poor control of the trunk and head, Patients who, due to the permanence in a sitting or lying position, have an average risk index of onset of pressure ulcers (according to the Norton or Braden scale), for which the transpiration of the surfaces (back and seat) is decisive for the maintenance of dry skin, to avoid skin maceration and topical infections. Patients with severe structured spinal deformities, in particular major kyphoscoliosis. Patients with difficulty in controlling and tending to lose the proper position of the pelvis, in order to slide forward.

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
41512	Push-rim manual wheelchair, non-bariatric	A non-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize by pushing specially designed rims on the wheels while seated. It is designed with a pair of larger wheels with push-rims attached whereby the occupant propels the device by rotating both wheels; it typically includes rear-fitted handles designed for optional pushing by an attendant. It provides no function outside of wheeled mobilization.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08055715702291	GS1