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510(k) K093946

HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 by Hoveround Corp. — Product Code ILK

K093946 is an FDA 510(k) premarket notification submitted by Hoveround Corp. for the device "HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2". The FDA issued a decision of Substantially Equivalent on March 22, 2010. The device falls under product code ILK (Transport, Patient, Powered), a Class II device regulated under 21 CFR 890.5150. Hoveround Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2010
Date Received
December 23, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transport, Patient, Powered
Device Class
Class II
Regulation Number
890.5150
Review Panel
PM
Submission Type

A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.

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)
  • 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)
  • K043069 — HOVEROUND E100 POWER CHAIR (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 ILK

  • K240843 — GENESIS (MS-P02-GEN) (October 7, 2024)
  • K222818 — Xpedition ™ Powered Stair Chair (625700000000) (January 24, 2023)
  • K130864 — C-MAX+ (PLUS) (February 6, 2014)
  • K121560 — LEVANT, HOMEGLIDE (November 1, 2012)
  • K121561 — FLOW2, SWING (October 26, 2012)
  • K113308 — BRUNO ELAN STAIRWAY ELEVATOR (February 1, 2012)
  • K111858 — LIFTKAR PT (November 4, 2011)
  • K103122 — C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION (December 30, 2010)
  • K091858 — PINNACLE STAIR WAY LIFT (July 1, 2009)
  • K073110 — MERITS E600 SERIES STAIR LIFT (February 6, 2008)

FDA data resources