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510(k) K202379

Invacare AVIVA Storm RX Power Chair by Invacare Corporation — Product Code ITI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2021
Date Received
August 20, 2020
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 Corporation

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  • K192216 — Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP (January 2, 2020)
  • K191159 — Concentrator with Single battery pack, carry bag with shoulder strap, back pack (August 29, 2019)
  • K182946 — Invacare TDX SP2-HD with Captain's Seat (December 11, 2018)
  • K181090 — Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs (November 14, 2018)
  • K170507 — Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP (July 12, 2017)
  • K162621 — Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide (April 17, 2017)
  • K162696 — Kuschall Advance Manual Wheelchair (December 28, 2016)
  • K162686 — Kuschall Champion Manual Wheelchair (December 28, 2016)

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)
  • K251458 — Electric Wheelchair (DH01168) (January 15, 2026)
  • K253276 — Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E (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)