Identity
- Trade Name
- STANDY FDA UDI
- Generic Name
- Manual stander FDA UDI
- Device Name
- Vertical standing frame for the acquisition and maintenance of an upright position and the training of the antigravity muscles of young, adult or elderly who cannot acquire and maintain them independently. Indicated for persons with functional deficits in verticalization and in maintaining an upright position, who have a minimum residual control of the trunk and head; users suffering from pathologies with alteration and impairment of the residual postural control, in which the load on the lower limbs is allowed, to improve bone density, ventilatory capacity, intestinal peristalsis, bladder function, blood circulation. FDA UDI
- Model / Reference
- STANDY-4 large FDA UDI
- Description
- Vertical standing frame for the acquisition and maintenance of an upright position and the training of the antigravity muscles of young, adult or elderly who cannot acquire and maintain them independently. Indicated for persons with functional deficits in verticalization and in maintaining an upright position, who have a minimum residual control of the trunk and head; users suffering from pathologies with alteration and impairment of the residual postural control, in which the load on the lower limbs is allowed, to improve bone density, ventilatory capacity, intestinal peristalsis, bladder function, blood circulation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08055715705094 FDA UDI
- FDA Product Code
- INM FDA UDI
- GMDN Term
- Manual stander 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: Manual stander
Standy 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 0f9b5a8d-08a6-45bf-b52c-94b8c68272c1 33 fields · synced May 30, 2026