ILK · Class II · 21 CFR 890.5150

FDA Product Code ILK: Transport, Patient, Powered

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.

Leading manufacturers include Bruno Independent Living Aids, Inc., Thyssenkrupp Accessibility B.V. and Aat Alber Antriebstechnik GmbH.

36
Total
36
Cleared
78d
Avg days
1977
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Transport, Patient, Powered Devices (Product Code ILK)

36 devices
1–24 of 36
Cleared Oct 07, 2024
GENESIS (MS-P02-GEN)
K240843
Climbing Steps, Inc.
Physical Medicine · 194d
Cleared Jan 24, 2023
Xpedition ™ Powered Stair Chair (625700000000)
K222818
Stryker Medical
Physical Medicine · 127d
Cleared Feb 06, 2014
C-MAX+ (PLUS)
K130864
Aat Alber Antriebstechnik GmbH
Physical Medicine · 315d
Cleared Nov 01, 2012
LEVANT, HOMEGLIDE
K121560
Thyssenkrupp Accessibility B.V.
Physical Medicine · 156d
Cleared Oct 26, 2012
FLOW2, SWING
K121561
Thyssenkrupp Accessibility B.V.
Physical Medicine · 150d
Cleared Feb 01, 2012
BRUNO ELAN STAIRWAY ELEVATOR
K113308
Bruno Independent Living Aids, Inc.
Physical Medicine · 84d
Cleared Nov 04, 2011
LIFTKAR PT
K111858
Sano Transportgeraete GmbH
Physical Medicine · 127d
Cleared Dec 30, 2010
C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG
K103122
Aat Alber Antriebstechnik GmbH
Physical Medicine · 70d
Cleared Mar 22, 2010
HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2
K093946
Hoveround Corp.
Physical Medicine · 89d
Cleared Jul 01, 2009
PINNACLE STAIR WAY LIFT
K091858
Summit Harmar, LLC
Physical Medicine · 8d
Cleared Feb 06, 2008
MERITS E600 SERIES STAIR LIFT
K073110
Merits Health Products Co., Ltd.
Physical Medicine · 93d
Cleared Aug 26, 1997
BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM
K970927
Bruno Independent Living Aids, Inc.
Physical Medicine · 166d
Cleared May 26, 1988
STAIR VEYOR
K882091
Pride Health Care, Inc.
Physical Medicine · 7d

About Product Code ILK - Regulatory Context

510(k) Submission Activity

36 total 510(k) submissions under product code ILK since 1977, with 36 receiving FDA clearance (average review time: 78 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.