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FRAME RUNNER

ORMESA SRL · Model FRAME RUNNER LARGE FISS.3R26" · UDI-DI 08054040401282

ION

510(k) clearances

116

Adverse events (2 deaths)

Recalls

255

Facilities

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.

Recalls

Date	Firm	Reason
2015-03-27	Amtryke LLC	Product is being recalled due to complaints of cracked frames.
2011-07-11	North Coast Medical Inc	Potential for plastic D-ring to break during use and cause injury.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.