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510(k) K023589

STORM TDX POWER WHEELCHAIR by Invacare Corp. — Product Code ITI

K023589 is an FDA 510(k) premarket notification submitted by Invacare Corp. for the device "STORM TDX POWER WHEELCHAIR". The FDA issued a decision of Substantially Equivalent on November 19, 2002. The device falls under product code ITI (Wheelchair, Powered), a Class II device regulated under 21 CFR 890.3860. Invacare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2002
Date Received
October 25, 2002
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)
  • K021685 — VENTURE HOMEFILL II WITH OXYGEN CONSERVER (July 23, 2002)

Other clearances for product code ITI

  • K261149 — Electric Wheelchair (DY611A-2, DY612A-1) (July 10, 2026)
  • K261396 — Electric Wheelchair (July 8, 2026)
  • K261164 — Electric wheelchair (XW-LY007 ) (July 7, 2026)
  • K260937 — Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) (June 24, 2026)
  • K253812 — Power Wheelchair (W5915B, W5915C, W5915D) (June 18, 2026)
  • K260335 — Electric Wheelchair (S500-6) (June 15, 2026)
  • K261175 — WHILL (WHILL Model C2) (June 12, 2026)
  • K260056 — Power Wheelchair (N5515A, N5516, N5517A, N5519) (June 5, 2026)
  • K260373 — Electric Wheelchair (DF506) (June 3, 2026)
  • K253241 — Electric Wheelchair (Y207BL) (May 13, 2026)

FDA data resources