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510(k) K043069

HOVEROUND E100 POWER CHAIR by Hoveround Corp. — Product Code ITI

K043069 is an FDA 510(k) premarket notification submitted by Hoveround Corp. for the device "HOVEROUND E100 POWER CHAIR". The FDA issued a decision of Substantially Equivalent on December 3, 2004. The device falls under product code ITI (Wheelchair, Powered), a Class II device regulated under 21 CFR 890.3860. Hoveround Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2004
Date Received
November 8, 2004
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 Hoveround Corp.

  • K122741 — HOVEROUND TEKNIQUE (May 7, 2013)
  • K122707 — HOVERROUND TEKNIQUE (May 7, 2013)
  • K100527 — HOVEROUND TEKNIQUE, MODEL HD-6 (March 26, 2010)
  • K093946 — HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 (March 22, 2010)
  • K100350 — HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GT (March 22, 2010)
  • K090108 — HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR (March 19, 2009)
  • K042920 — HOVEROUND SE-3 POWERCHAIR (December 3, 2004)
  • K042545 — HOVEROUND MPV-5 POWERCHAIR (October 21, 2004)
  • K042033 — HOVEROUND POWER WHEELCHAIR, MODEL HD700 (September 29, 2004)
  • K022993 — HOVEROUND REHAB SEATING SYSTEM FOR POWER WHEELCHAIRS (December 2, 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