FRAME RUNNER

Primary DI
08054040401329
Brand
FRAME RUNNER
Company
ORMESA SRL
Model
FRAME RUNNER MEDIUM RIB.2R24"1R20"
Device 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.
Published
2025-09-20
Public version status
Update
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 table
CodeName
IONExerciser, Non-Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IONExerciser, Non-MeasuringPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08054040401329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054040401329080540404013298054040401329

GMDN Terms#

Term, Definition table
TermDefinition
Assistive foot-propelled tricycleA vehicle with three wheels mounted on a slender frame which the user with a disability sits astride and pedals with their legs to provide a means of transportation, typically without the attendance of another person. It is designed to be operated by the user. The vehicle will enhance the user's independence in short- to medium-range transportation.

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
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054040400612ADJUSTABLE TROLLIADJUSTABLE TROLLI 36 NERO+951+8232026-09-06
08054040400629ADJUSTABLE TROLLIADJUSTABLE TROLLI 36 ROSSO+951+8232026-09-06
08054040400636ADJUSTABLE TROLLIADJUSTABLE TROLLI 40 ROSSO+951+8232026-09-06
08054040400643ADJUSTABLE TROLLIADJUSTABLE TROLLI 40 NERO +951+8232026-09-06
08054040400650ADJUSTABLE TROLLIADJUSTABLE TROLLI 43 NERO +951+8232026-09-06
08054040400667ADJUSTABLE TROLLIADJUSTABLE TROLLI 43 ROSSO+951+8232026-09-06
08054040402074ADJUSTABLE TROLLITROLLI REGOLABILE 36 NERO+823+9582026-09-06
08054040402081ADJUSTABLE TROLLITROLLI REGOLABILE 40 NERO+823+9582026-09-06
08054040402098ADJUSTABLE TROLLITROLLI REGOLABILE 43 NERO+823+9582026-09-06
08054040402104ADJUSTABLE TROLLITROLLI REGOLABILE-40 ROSSO 8632026-09-06
08054040402111ADJUSTABLE TROLLITROLLI REGOLABILE-36 ROSSO 8632026-09-06
08054040402128ADJUSTABLE TROLLITROLLI REGOLABILE-43 ROSSO 8632026-09-06
08054040402210ADJUSTABLE TROLLITROLLI REGOLABILE 36 ROSSO+823+9582026-09-06
08054040402227ADJUSTABLE TROLLITROLLI REGOLABILE-36 NERO 951,8632026-09-06
08054040402234ADJUSTABLE TROLLITROLLI REGOLABILE-36 ROSSO 951,8632026-09-06
08054040402241ADJUSTABLE TROLLITROLLI REGOLABILE-40 NERO 951,8632026-09-06
08054040402258ADJUSTABLE TROLLITROLLI REGOLABILE-40 ROSSO 951,8632026-09-06
08054040402265ADJUSTABLE TROLLITROLLI REGOLABILE-43 NERO 951,8632026-09-06
08054040402272ADJUSTABLE TROLLITROLLI REGOLABILE-43 ROSSO 951,8632026-09-06
08054040402289ADJUSTABLE TROLLITROLLI REGOLABILE 36 NERO+823+9582026-09-06

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