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ARYS me

tyromotion GmbH · Model 3 · UDI-DI 09120077180113

ION
10
510(k) clearances
117
Adverse events (2 deaths)
2
Recalls
255
Facilities

Description

ARYS me is intended for over-the-counter use for self-directed management of arm rehabilitation without specific treatment or treatment recommendations.

Recalls

DateFirmReason
2015-03-27Amtryke LLCProduct is being recalled due to complaints of cracked frames.
2011-07-11North Coast Medical IncPotential 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.