C.T.M. Mobility Scooter, Hs-528

• • Terminated Z-0774-2012 FDA Unclassified (pre-2012) ·initiated 7 Dec 2011

  Invacare Corporation decided to recall the products because the scooter backrest fails unexpectedly due to seat flexing, and this has the potential to result in a consumer falling causing death or serious injury.

510(k) Number

K090735 ↗

FDA Product Code

INI

Device Class

Class II

Regulation

21 CFR Part 890.3800

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• C.T.M. Mobility Scooter, Model Hs-235

  Class II

  FDA 510(k) K032918 Active Cleared 6 Oct 2003

• C.T.M. Power Chair, Model Hs-1000

  Class II

  FDA 510(k) K040020 Active Cleared 18 Feb 2004

• C.T.M. Mobility Scooter, Model Hs-120

  Class II

  FDA 510(k) K031272 Active Cleared 20 May 2003

• C.T.M. Mobility Scooter HS515(3W)

  Class II

  FDA 510(k) K110567 Active Cleared 22 Apr 2011

• C.T.M. Mobility Scooter - Model Hs 118

  Class II

  FDA 510(k) K110395 Active Cleared 22 Apr 2011

• C.T.M. Mobility Scooter, Model HS-628, Invacare Orion

  Class II

  FDA 510(k) K091418 Active Cleared 6 Jul 2009

See all devices from C.T.M. Homecare Product, Inc. →