ILK · Transport, Patient, Powered
Physical Medicine · 21 CFR 890.5150 · Class 2
Overview
| Product Code | ILK |
|---|---|
| Device Name | Transport, Patient, Powered |
| Regulation | 21 CFR 890.5150 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
| 3rd-Party Reviewable | Yes |
Identification
Powered patient stairway chair lifts: A powered patient stairway chair lift is a motorized lift equipped with a seat and permanently mounted in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway. All other powered patient transport: 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.
Classification Rationale
Class II. The stairway chair lift is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9 and the following conditions for exemption. All other powered patient transport is Class II.
Special Controls
(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of American Society of Mechanical Engineers (ASME) A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the chair in the event of a device failure; (ii) Appropriate analysis and nonclinical testing must demonstrate the ability of the device, including armrests, to withstand the rated load with an appropriate factor of safety; (iii) Appropriate restraints must be provided to prevent the user from falling from the device (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”); (iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety; and (v) Appropriate analysis and nonclinical testing must demonstrate the resistance of the device upholstery to ignition.
Recent Cleared Devices (20 of 36)
Showing 20 most recent of 36 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240843 | GENESIS (MS-P02-GEN) | Climbing Steps, Inc. | Oct 7, 2024 | SESE |
| K222818 | Xpedition Powered Stair Chair (625700000000) | Stryker Medical | Jan 24, 2023 | SESE |
| K130864 | C-MAX+ (PLUS) | Aat Alber Antriebstechnik GmbH | Feb 6, 2014 | SESE |
| K121560 | LEVANT, HOMEGLIDE | Thyssenkrupp Accessibility B.V. | Nov 1, 2012 | SESE |
| K121561 | FLOW2, SWING | Thyssenkrupp Accessibility B.V. | Oct 26, 2012 | SESE |
| K113308 | BRUNO ELAN STAIRWAY ELEVATOR | Bruno Independent Living Aids, Inc. | Feb 1, 2012 | SESE |
| K111858 | LIFTKAR PT | Sano Transportgeraete GmbH | Nov 4, 2011 | SESE |
| 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 | Aat Alber Antriebstechnik GmbH | Dec 30, 2010 | SESE |
| K093946 | HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 | Hoveround Corp. | Mar 22, 2010 | SESE |
| K091858 | PINNACLE STAIR WAY LIFT | Summit Harmar, LLC | Jul 1, 2009 | SESE |
| K073110 | MERITS E600 SERIES STAIR LIFT | Merits Health Products Co., Ltd. | Feb 6, 2008 | SESE |
| K033829 | BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100 | Bruno Independent Living Aids, Inc. | Dec 29, 2003 | SESE |
| K033752 | BRUNO ELECTRA-RIDE STAIRWAY ELEVATOR SYSTEM. MODEL SRE-1540 | Bruno Independent Living Aids, Inc. | Dec 12, 2003 | SESE |
| K033438 | BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000 | Bruno Independent Living Aids, Inc. | Nov 20, 2003 | SESE |
| K032880 | SUMMIT STAIRWAY LIFT | Summit Lifts, Inc. | Nov 10, 2003 | SESE |
| K023852 | STAIRFRIEND CURVED STAIRWAY CHAIRLIFT | Services Industriels Savaria, Inc. | Mar 4, 2003 | SESE |
| K024345 | B.07 STAIRWAY CHAIRLIFT | Services Industriels Savaria, Inc. | Feb 26, 2003 | SESE |
| K024167 | STEP-SAVER STAIRWAY CHAIRLIFT | Services Industriels Savaria, Inc. | Feb 6, 2003 | SESE |
| K022509 | BRUNO ELECTRA-RIDE, MODEL SRE-2700 | Bruno Independent Living Aids, Inc. | Aug 13, 2002 | SESE |
| K970927 | BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM | Bruno Independent Living Aids, Inc. | Aug 26, 1997 | SESE |
Top Applicants
- Bruno Independent Living Aids, Inc. — 7 clearances
- Services Industriels Savaria, Inc. — 3 clearances
- Aat Alber Antriebstechnik GmbH — 2 clearances
- T.B.S., Inc. — 2 clearances
- Thyssenkrupp Accessibility B.V. — 2 clearances
