Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5150](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5150) → ILK — Transport, Patient, Powered # ILK · Transport, Patient, Powered _Physical Medicine · 21 CFR 890.5150 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILK ## Overview - **Product Code:** ILK - **Device Name:** Transport, Patient, Powered - **Regulation:** [21 CFR 890.5150](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5150) - **Device Class:** 2 - **Review Panel:** [Physical Medicine](/submissions/PM) - **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](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILK/K240843.md) | GENESIS (MS-P02-GEN) | Climbing Steps, Inc. | Oct 7, 2024 | SESE | | [K222818](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILK/K222818.md) | Xpedition ™ Powered Stair Chair (625700000000) | Stryker Medical | Jan 24, 2023 | SESE | | [K130864](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILK/K130864.md) | C-MAX+ (PLUS) | Aat Alber Antriebstechnik GmbH | Feb 6, 2014 | SESE | | [K121560](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILK/K121560.md) | LEVANT, HOMEGLIDE | Thyssenkrupp Accessibility B.V. | Nov 1, 2012 | SESE | | [K121561](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILK/K121561.md) | FLOW2, SWING | Thyssenkrupp Accessibility B.V. | Oct 26, 2012 | SESE | | [K113308](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILK/K113308.md) | BRUNO ELAN STAIRWAY ELEVATOR | Bruno Independent Living Aids, Inc. | Feb 1, 2012 | SESE | | [K111858](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILK/K111858.md) | LIFTKAR PT | Sano Transportgeraete GmbH | Nov 4, 2011 | SESE | | [K103122](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILK/K103122.md) | 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](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILK/K093946.md) | HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 | Hoveround Corp. | Mar 22, 2010 | SESE | | [K091858](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILK/K091858.md) | PINNACLE STAIR WAY LIFT | Summit Harmar, LLC | Jul 1, 2009 | SESE | | [K073110](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILK/K073110.md) | MERITS E600 SERIES STAIR LIFT | Merits Health Products Co., Ltd. | Feb 6, 2008 | SESE | | [K033829](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILK/K033829.md) | BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100 | Bruno Independent Living Aids, Inc. | Dec 29, 2003 | SESE | | [K033752](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILK/K033752.md) | BRUNO ELECTRA-RIDE STAIRWAY ELEVATOR SYSTEM. MODEL SRE-1540 | Bruno Independent Living Aids, Inc. | Dec 12, 2003 | SESE | | [K033438](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILK/K033438.md) | BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000 | Bruno Independent Living Aids, Inc. | Nov 20, 2003 | SESE | | [K032880](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILK/K032880.md) | SUMMIT STAIRWAY LIFT | Summit Lifts, Inc. | Nov 10, 2003 | SESE | | [K023852](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILK/K023852.md) | STAIRFRIEND CURVED STAIRWAY CHAIRLIFT | Services Industriels Savaria, Inc. | Mar 4, 2003 | SESE | | [K024345](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILK/K024345.md) | B.07 STAIRWAY CHAIRLIFT | Services Industriels Savaria, Inc. | Feb 26, 2003 | SESE | | [K024167](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILK/K024167.md) | STEP-SAVER STAIRWAY CHAIRLIFT | Services Industriels Savaria, Inc. | Feb 6, 2003 | SESE | | [K022509](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILK/K022509.md) | BRUNO ELECTRA-RIDE, MODEL SRE-2700 | Bruno Independent Living Aids, Inc. | Aug 13, 2002 | SESE | | [K970927](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILK/K970927.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILK](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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