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Juditta

FDA UDI

Class I (US FDA UDI)

by Ormesa Srl

Identity

Trade Name
JUDITTA FDA UDI
Generic Name
Attendant-only-propelled wheelchair, non-bariatric FDA UDI
Device Name
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. FDA UDI
Model / Reference
JUDITTA-36 B30 DARK GREY, BLACK FRAME FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
08055715701461 FDA UDI
FDA Product Code
INM FDA UDI
GMDN Term
Attendant-only-propelled wheelchair, non-bariatric FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Attendant-only-propelled wheelchair, non-bariatric

Juditta by Ormesa Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Attendant-only-propelled wheelchair, non-bariatric.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ormesa Srl

Sources (1)

  • FDA UDI 353746ce-6b69-42dd-94ad-736670346d6b 33 fields · synced May 30, 2026