510(k) K093946

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

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.

K122707 — HOVERROUND TEKNIQUE (May 7, 2013)
K122741 — HOVEROUND 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)
K043069 — HOVEROUND E100 POWER CHAIR (December 3, 2004)
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 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)