DONDOLINO
- Primary DI
- 08055715705506
- Brand
- DONDOLINO
- Company
- ORMESA SRL
- Model
- DONDOLINO 2
- Device description
- Tilting vertical standing frame indicated for the acquisition and maintenance of an upright position and the training of the antigravity muscles of children who cannot acquire and maintain them independently. Indicated for users suffering from pathologies that determine a deficit of postural control, in which the load of the lower limbs is still allowed, to improve bone density, ventilatory capacity, intestinal peristalsis, bladder function, blood circulation and for such as the semi-prone positioning, allows to stimulate the straightening reactions of the trunk and head and to work against gravity.
- Published
- 2025-01-31
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| INM | Chair, With Casters |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| INM | Chair, With Casters | Physical Medicine | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08055715705506 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Manual stander | A manually-powered, mobile device designed to support and lift a disabled (paraplegic) patient to an upright standing position to provide the health benefits associated with standing (e.g., improved breathing, circulation, and flexibility); it is neither intended to facilitate gait nor assist standing transfer. It typically consists of a seat, sling and/or platform with appropriate supports (e.g., footplates, kneepads, chest pad), wheels, and a manual mechanical lifting mechanism whereby the patient is raised from a supine, prone, and/or seated position by themselves or with the assistance of a healthcare provider. It includes wheels for reorientation. |
Regulatory Flags
- DUNS number
- 432070019
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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