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510(k) K062402

EASYSTAND EVOLV by Invacare Corp. — Product Code INO

K062402 is an FDA 510(k) premarket notification submitted by Invacare Corp. for the device "EASYSTAND EVOLV". The FDA issued a decision of Substantially Equivalent on September 21, 2006. The device falls under product code INO (Chair, Positioning, Electric), a Class II device regulated under 21 CFR 890.3110. Invacare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2006
Date Received
August 17, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Positioning, Electric
Device Class
Class II
Regulation Number
890.3110
Review Panel
PM
Submission Type

Other clearances by Invacare Corp.

  • K071928 — THE INVACARE FLYER, MODEL IPC 100 (December 12, 2007)
  • K070321 — TWILIGHT FULL FACE MASK (April 30, 2007)
  • K061874 — INVACARE'S TWILIGHT II NASAL MASKS (September 5, 2006)
  • K033819 — INVACARE 3G TARSYS (June 4, 2004)
  • K031176 — INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 (March 25, 2004)
  • K031064 — INVACARE POLARIS EX CPAP, MODEL ISP3000 (March 12, 2004)
  • K030814 — INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3 (March 20, 2003)
  • K022642 — TWLIGHT, MODEL ISP 9600 (February 11, 2003)
  • K023589 — STORM TDX POWER WHEELCHAIR (November 19, 2002)
  • K021685 — VENTURE HOMEFILL II WITH OXYGEN CONSERVER (July 23, 2002)

Other clearances for product code INO

  • K131909 — DALTON LIFT CHAIR (February 24, 2014)
  • K123834 — EASYSTAND BANTAM MEDIUM (August 13, 2013)
  • K112944 — FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES (December 30, 2011)
  • K101723 — COMPACT WHEELCHAIR PLATFORM (December 23, 2010)
  • K091578 — LIFT CHAIR, MODEL T3 (December 2, 2009)
  • K091727 — MEDICAL TREATMENT CHAIR, T400, T500,T600 (July 6, 2009)
  • K091242 — BANTAM (July 6, 2009)
  • K073565 — STANDARD WHEELCHAIR PLATFORM (February 6, 2009)
  • K081053 — PIVOT ASSIST (October 9, 2008)
  • K080533 — WINCO MODEL POWER SERIES LIFT CHAIR (August 11, 2008)

FDA data resources