Product Code: ILK FDA class 2 21 CFR 890.5150

Transport, Patient, Powered

Physical Medicine

A Powered Patient Transport device is a motorized conveyance used in Physical Medicine to move patients with limited mobility safely between locations within a healthcare facility, reducing manual handling burden on caregivers and risk of patient injury. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is ILK, regulated under 21 CFR 890.5150, within the Physical Medicine medical specialty. This device is eligible for third party review, meaning the 510(k) submission may be reviewed by an FDA-accredited third party organization.

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510(k)s

FEI Numbers

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Unique Applicants

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Basic Information

Product Code: ILK
Device Class: FDA class 2
Regulation Number: 890.5150
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

Definition

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.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 36 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K240843	GENESIS (MS-P02-GEN)	Oct 07, 2024	Substantially Equivalent	Climbing Steps, Inc.
K222818	Xpedition Powered Stair Chair (625700000000)	Jan 24, 2023	Substantially Equivalent	Stryker Medical
K130864	C-MAX+ (PLUS)	Feb 06, 2014	Substantially Equivalent	Aat Alber Antriebstechnik GmbH
K121560	LEVANT, HOMEGLIDE	Nov 01, 2012	Substantially Equivalent	Thyssenkrupp Accessibility B.V.
K121561	FLOW2, SWING	Oct 26, 2012	Substantially Equivalent	Thyssenkrupp Accessibility B.V.
K113308	BRUNO ELAN STAIRWAY ELEVATOR	Feb 01, 2012	Substantially Equivalent	Bruno Independent Living Aids, Inc.
K111858	LIFTKAR PT	Nov 04, 2011	Substantially Equivalent	Sano Transportgeraete GmbH
K103122	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	Dec 30, 2010	Substantially Equivalent	Aat Alber Antriebstechnik GmbH
K093946	HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2	Mar 22, 2010	Substantially Equivalent	Hoveround Corp.
K091858	PINNACLE STAIR WAY LIFT	Jul 01, 2009	Substantially Equivalent	Summit Harmar, LLC
K073110	MERITS E600 SERIES STAIR LIFT	Feb 06, 2008	Substantially Equivalent	Merits Health Products Co., Ltd.
K033829	BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100	Dec 29, 2003	Substantially Equivalent	Bruno Independent Living Aids, Inc.
K033752	BRUNO ELECTRA-RIDE STAIRWAY ELEVATOR SYSTEM. MODEL SRE-1540	Dec 12, 2003	Substantially Equivalent	Bruno Independent Living Aids, Inc.
K033438	BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000	Nov 20, 2003	Substantially Equivalent	Bruno Independent Living Aids, Inc.
K032880	SUMMIT STAIRWAY LIFT	Nov 10, 2003	Substantially Equivalent	Summit Lifts, Inc.
K023852	STAIRFRIEND CURVED STAIRWAY CHAIRLIFT	Mar 04, 2003	Substantially Equivalent	Services Industriels Savaria, Inc.
K024345	B.07 STAIRWAY CHAIRLIFT	Feb 26, 2003	Substantially Equivalent	Services Industriels Savaria, Inc.
K024167	STEP-SAVER STAIRWAY CHAIRLIFT	Feb 06, 2003	Substantially Equivalent	Services Industriels Savaria, Inc.
K022509	BRUNO ELECTRA-RIDE, MODEL SRE-2700	Aug 13, 2002	Substantially Equivalent	Bruno Independent Living Aids, Inc.
K970927	BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM	Aug 26, 1997	Substantially Equivalent	Bruno Independent Living Aids, Inc.
K932625	STAIR ASSIST(TM) POWERED GRAB BAR TRANSPORT	Sep 30, 1993	Substantially Equivalent	Stair Assist Corp.
K923912	MOORE MANUFACTURE MODEL-MHBTL	Feb 12, 1993	Substantially Equivalent	Moore Mfg., Inc.
K921648	BRUNO ELECTRA-RIDE STAIR-WAY ELEVATOR SYSTEM	May 04, 1992	Substantially Equivalent	Bruno Independent Living Aids, Inc.
K896628	LIBERTY SPECIAL AND LIBERTY STAIRLIFTS	Jan 12, 1990	Substantially Equivalent	The Cheney Co.
K890555	PATIENT MOVER(TM)	Feb 13, 1989	Substantially Equivalent	T.B.S., Inc.
K884110	LTDT PATIENT LIFTER	Oct 13, 1988	Substantially Equivalent	Devine Medical Products
K882669	APPOLLO BATH	Jul 08, 1988	Substantially Equivalent	Electric Mobility, LLC
K882091	STAIR VEYOR	May 26, 1988	Substantially Equivalent	Pride Health Care, Inc.
K871582	PATIENT MOVER(TM)	May 06, 1987	Substantially Equivalent	T.B.S., Inc.
K864152	BACK SAVER LIFT BELT/WHEELCHAIR TRANSFER DEVICE	Feb 05, 1987	Substantially Equivalent	Lossing Orthopedic, Inc.
K864324	ELECTRIFIED TRANSFER TOILET SEAT	Dec 16, 1986	Substantially Equivalent	Robert E. Roy
K862738	DANIEL ORTHO BED LIFT AC	Jul 29, 1986	Substantially Equivalent	Radco
K854461	HANDI-MOVE	Mar 14, 1986	Substantially Equivalent	T.F. Herceg, Inc.
K850877	MONOLIFT MPE2, PLATFORM, CHAIR, FULLY FUTO PLATFOR	Jun 12, 1985	Substantially Equivalent	Ketronic, Inc.
K803063	STRAP EASE 400	Dec 22, 1980	Substantially Equivalent	Independent Transfer Equipment Co.
K770294	PORT-A-BATH	Mar 30, 1977	Substantially Equivalent	Kathco, Inc.