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510(k) K013516

INVACARE ELEVATING SEAT OPTION ESS6 by Invacare Corp. — Product Code ITI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2001
Date Received
October 23, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wheelchair, Powered
Device Class
Class II
Regulation Number
890.3860
Review Panel
PM
Submission Type

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets “mobility to persons restricted to a sitting position” to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. NOTE: This type of device is not intended to climb stairs (see product code: IMK).

Other clearances by Invacare Corp.

  • K071928 — THE INVACARE FLYER, MODEL IPC 100 (December 12, 2007)
  • K070321 — TWILIGHT FULL FACE MASK (April 30, 2007)
  • K062402 — EASYSTAND EVOLV (September 21, 2006)
  • 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)

Other clearances for product code ITI

  • K253870 — Electric Wheelchair (MP148) (March 4, 2026)
  • K253789 — Electric wheelchair (February 25, 2026)
  • K253707 — Electric wheelchair (W1,W3) (February 24, 2026)
  • K253599 — Electric Wheelchair (W-A807, W-A807L) (February 17, 2026)
  • K253276 — Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E (January 15, 2026)
  • K251458 — Electric Wheelchair (DH01168) (January 15, 2026)
  • K251159 — Power wheelchair (December 22, 2025)
  • K252862 — Electric Wheelchair (DH01126) (December 8, 2025)
  • K252494 — Electrically powered wheelchair (KZ301B) (December 5, 2025)
  • K252829 — Powered Wheelchair (PL001-9001) (November 12, 2025)