Identity
- Trade Name
- TROLLI FDA UDI
- Generic Name
- Assistive pushchair FDA UDI
- Device Name
- TROLLI is a wheelchair designed to facilitate the displacement of adults and children with walking issues: subjects with pathological pictures that do not require specific postural measures and that do not have complete autonomy. It allows the positioning of the user with disabilities of varying complexity, in the most appropriate and functional posture in the different everyday environments. The postural components (supports and belts) allow to give stability to the pelvis, lower limbs and trunk. It can be used even in medium severity circumstances, in outdoor and indoor environments, for the transport of those subjects, who are not able to independently maintain the seating posture due to severe disorders of the nervous and muscle system or of the rational sphere. FDA UDI
- Model / Reference
- TROLLI T60 size 43 WITH SELF- PROPELLING WHEELS with 951 Height adjustable push FDA UDI
- Description
- TROLLI is a wheelchair designed to facilitate the displacement of adults and children with walking issues: subjects with pathological pictures that do not require specific postural measures and that do not have complete autonomy. It allows the positioning of the user with disabilities of varying complexity, in the most appropriate and functional posture in the different everyday environments. The postural components (supports and belts) allow to give stability to the pelvis, lower limbs and trunk. It can be used even in medium severity circumstances, in outdoor and indoor environments, for the transport of those subjects, who are not able to independently maintain the seating posture due to severe disorders of the nervous and muscle system or of the rational sphere. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08055715708019 FDA UDI
- FDA Product Code
- INM FDA UDI
- GMDN Term
- Assistive pushchair 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: Assistive pushchair
Trolli by Ormesa Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ormesa Srl
Sources (1)
- FDA UDI 30f74051-33a1-481b-9616-e6bb03fb91b3 33 fields · synced May 30, 2026