Quickie Rhythm & Groove Series Power Wheelchairs W/Quickie Delphi Controls

• 2 recalls, same reason

  • Terminated Z-1531-2008 FDA Unclassified (pre-2012) ·initiated 11 Jan 2008
  • Terminated Z-1532-2008 FDA Unclassified (pre-2012) ·initiated 11 Jan 2008

  Product experiences a longer than expected stopping distance, which may cause injury to the user, objects, or the chair itself.

• • Terminated Z-1163-2007 FDA Unclassified (pre-2012) ·initiated 23 Apr 2007

  The wire harness connected to the display housing (Quickie IQ Enhanced Displays) may separate and cause sparks from a short circuit.

• • Terminated Z-2339-2008 FDA Unclassified (pre-2012) ·initiated 13 Nov 2006

  Rear bolts holding the frame in place may shear and the front bolts may potentially come off the posts, resulting in partial or full seat detachment in a sudden stop or crash.

510(k) Number

K060531 ↗

FDA Product Code

ITI

Device Class

Class II

Regulation

21 CFR Part 890.3860

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

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