FDA-Device2012-08-08Class II

Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions.

Sunrise Medical (US) LLC
Hazard

Reports of injury when the Padded Swing Away Armrest is used for full body weight. Owner's manual states that armrest is only designed for resting of forearm.

Sold states
Worldwide Distribution - US (nationwide) and the countries of Argentina, Brazil, Columbia, Costa Rica, Mexico, Panama, Uruguay and Venezuela.
Affected count
14, 035
Manufactured in
2842 N Business Park Ave, N/A, Fresno, CA, United States
Products
Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2113-2012

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