Quickie Zippie Series, Quickie Breezy Series, Quick Folding Series, Quickie Rigid Series

• • Terminated Z-1019-2015 FDA Class II ·initiated 19 Dec 2014

  There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs.

• • Terminated Z-2113-2012 FDA Class II ·initiated 26 Jun 2012

  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.

• • Terminated Z-1103-2012 FDA Not yet classified ·initiated 13 Jan 2012

  One Zippie TS Wheelchair was made per customer order was shipped with transit brackets for use a seat in a motor vehicle, however the chair was not configured with a back tested seat for motor vehicle use.

• • Terminated Z-0831-2011 FDA Unclassified (pre-2012) ·initiated 2 Feb 2009

  The stabilizer bar was inadvertently omitted during the manufacturing process.

510(k) Number

K973673 ↗

FDA Product Code

IOR

Device Class

Class I

Regulation

21 CFR Part 890.3850

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Devilbiss Intellipap Model Dv 5 Series

  Class II

  FDA 510(k) K071689 Active Cleared 7 Sep 2007

• Devilbiss Oxygen Cylinder Filling System 535 Series

  Class II

  FDA 510(k) K053240 Active Cleared 3 Feb 2006

• Quickie Interchange Fwd W/Lift Power Wheelchair

  Class II

  FDA 510(k) K043435 Active Cleared 11 Feb 2005

• Quickie Freestyle Power Wheelchair, Model G-424

  Class II

  FDA 510(k) K031289 Active Cleared 9 May 2003

• Power Recliner

  Class II

  FDA 510(k) K944423 Active Cleared 28 Nov 1994

• Quickie Rhapsody, Mwd Series II Power Wheelchair

  Class II

  FDA 510(k) K062701 Active Cleared 25 Sep 2006

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