← Back to catalogue
Frame Runner Large Ribalt.3r26"
EUDAMEDFDA UDIClass I (EU MDR)
Ref 73Model FRAME RUNNER
Identity
- Trade Name
- FRAME RUNNER LARGE RIBALT.3R26" EUDAMEDFRAME RUNNER FDA UDI
- Generic Name
- Assistive foot-propelled tricycle FDA UDI
- Device Name
- FRAME RUNNER EUDAMEDThe Ormesa Frame Runner is intended for children/adults who need mobility and balance aids without which they would not be able to run, who have sufficient awareness and perception of the space around them. It is suitable for people with severe motor and coordination difficulties who can use the Frame Runner as a therapeutic and recreational activity: its use improves fitness and strength as well as physical and emotional well-being. Even those who have difficulty controlling their balance while walking can benefit from the use of the Frame Runner thanks to the stability provided by the entire system. FDA UDI
- Model / Reference
- FRAME RUNNER EUDAMED73 EUDAMEDFRAME RUNNER LARGE RIBALT.3R26 FDA UDI
- Description
- The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids without which they would not be able to run, who have sufficient awareness and perception of the space around them. It is suitable for people with severe motor and coordination difficulties who can use the Frame Runner as a therapeutic and recreational activity: its use improves fitness and strength as well as physical and emotional well-being. Even those who have difficulty controlling their balance while walking can benefit from the use of the Frame Runner thanks to the stability provided by the entire system. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08054040401305 EUDAMEDFDA UDI
- Basic UDI-DI
- 805404040FRAMERUNNERN4 EUDAMED
- FDA Product Code
- ION FDA UDI
- EMDN Code
- Y122799 NON-MOTORIZED VEHICLES AND MEANS OF TRANSPORT - OTHER EUDAMED
- GMDN Term
- Assistive foot-propelled tricycle FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5370 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Frame Runner Large Ribalt.3r26" by ORMESA S.r.l. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805404040FRAMERUNNERN4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ORMESA S.r.l.
- EUDAMED SRN
- IT-MF-000034824
Sources (2)
- EUDAMED 5e3c08cf-1b31-4126-846f-af0c4e09b0d6 61 fields · synced Jul 10, 2026
- FDA UDI 4733431e-3066-45b4-8f03-22cf85a290ee 33 fields · synced May 30, 2026