TROLLI
Basic Information
- Brand Name
- TROLLI
- Primary DI
- 08055715707746
- Version / Model
- TROLLI T60 MIS.40 DA AUTOSPINTA
- 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
- 2b338fec-0e8a-488c-920f-569910f0e2e9
Device 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.
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 |
|---|---|---|---|---|
| 31162 | Assistive pushchair | A wheeled mobility device manually propelled by an attendant that consists of a open framework with one or more handle(s) designed to carry one or more person(s) with a disability in a seated or semi-lying (semi-recumbent) position. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08055715707746 | GS1 |