Home GUDID 08054040401367 FRAME RUNNER
Primary DI 08054040401367
Brand FRAME RUNNER
Company ORMESA SRL
Model FRAME RUNNER LARGE RIB.3R24
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 Code Name ION Exerciser, Non-Measuring
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ION Exerciser, Non-Measuring Physical Medicine 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08054040401367 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08054040401367 08054040401367 8054040401367
GMDN Terms# Term, Definition table Term Definition Assistive foot-propelled tricycle A 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 DI Brand Model Catalog Published 08054040402159 JUDITTA JUDITTA-40 B60 TEL.NERO.SENZA TAPP 2026-08-27 08054040402166 JUDITTA JUDITTA-45 B60 TEL.NERO.SENZA TAPP 2026-08-27 08054040402173 JUDITTA JUDITTA-50 B60 TEL.NERO.SENZA TAPP 2026-08-27 08054040402180 JUDITTA JUDITTA 36-40 B30 932 T.NER.S/TAPP 2026-08-27 08054040402197 JUDITTA JUDITTA-45 B30 932 T.NERO.SENZ.TAPP 2026-08-27 08054040402203 JUDITTA JUDITTA-50 B30 932 T.NERO.SENZ.TAPP 2026-08-27 08054040403682 JUDITTA JUDITTA-45 B12 TEL.BIANC.TAPP.SCUR. SU MISURA 2026-08-27 08055715701294 JUDITTA JUDITTA-36 B30, TAPPEZZERIA GRIGIO CHIARO E TELAIO 2026-08-27 08055715701300 JUDITTA JUDITTA-36 B30, TAPPEZZERIA GRIGIO SCURO E TELAIO 2026-08-27 08055715701317 JUDITTA JUDITTA-36 B30, TAPPEZZERIA GRIGIO CHIARO E TELAIO 2026-08-27 08055715701324 JUDITTA JUDITTA-36 B30, TAPPEZZERIA GRIGIO SCURO E TELAIO 2026-08-27 08055715701331 JUDITTA JUDITTA-40 B30, TAPPEZZERIA GRIGIO CHIARO E TELAIO 2026-08-27 08055715701348 JUDITTA JUDITTA-40 B30, TAPPEZZERIA GRIGIO SCURO E TELAIO 2026-08-27 08055715701355 JUDITTA JUDITTA-40 B30, TAPPEZZERIA GRIGIO CHIARO E TELAIO 2026-08-27 08055715701362 JUDITTA JUDITTA-40 B30, TAPPEZZERIA GRIGIO SCURO E TELAIO 2026-08-27 08055715701379 JUDITTA JUDITTA-45 B30, TAPPEZZERIA GRIGIO CHIARO E TELAIO 2026-08-27 08055715701386 JUDITTA JUDITTA-45 B30, TAPPEZZERIA GRIGIO SCURO E TELAIO 2026-08-27 08055715701393 JUDITTA JUDITTA-45 B30, TAPPEZZERIA GRIGIO CHIARO E TELAIO 2026-08-27 08055715701409 JUDITTA JUDITTA-45 B30, TAPPEZZERIA GRIGIO SCURO E TELAIO 2026-08-27 08055715701416 JUDITTA JUDITTA-50 B30, TAPPEZZERIA GRIGIO CHIARO E TELAIO 2026-08-27
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