FDA UDI In Commercial Distribution 🇺🇸 United States

TROLLINO

DI: 08055715707180 · Model: TROLLINO RED · ORMESA SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
TROLLINO
Primary DI
08055715707180
Version / Model
TROLLINO RED
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
63dbc671-d389-425c-9a3b-baf2bf4bf84d

Device Description

TROLLINO is an assistive device for children and teens (95 - 140 cm tall) that need a system for mobility during everyday activities, with different levels of functional and postural needs. It allows the positioning of the user with disabilities of various complexity in the most appropriate and functional posture to the different contexts of daily life. The postural options (padded covers, harnesses, belts) allow to give stability to the pelvis, lower limbs, trunk and head, and to take different positions thanks to the reclining of the backrest. It can therefore be also used in medium gravity circumstances, in outdoor environments, for the transport of those users who are not able to maintain their sitting posture, due to severe diseases of the nervous system, of the muscular apparatus or relational sphere.

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
INM Chair, With Casters

GMDN Terms

Code Name
31162 Assistive pushchair

Identifiers

Type ID
Primary 08055715707180