ILK — Transport, Patient, Powered Class II
FDA product code ILK covers "Transport, Patient, Powered", a Class II medical device regulated under 21 CFR 890.5150. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ILK
- Device Class
- Class II
- Regulation Number
- 890.5150
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240843 | climbing steps | GENESIS (MS-P02-GEN) | October 7, 2024 |
| K222818 | stryker medical | Xpedition Powered Stair Chair (625700000000) | January 24, 2023 |
| K130864 | aat alber antriebstechnik | C-MAX+ (PLUS) | February 6, 2014 |
| K121560 | thyssenkrupp accessibility | LEVANT, HOMEGLIDE | November 1, 2012 |
| K121561 | thyssenkrupp accessibility | FLOW2, SWING | October 26, 2012 |
| K113308 | bruno independent living aids | BRUNO ELAN STAIRWAY ELEVATOR | February 1, 2012 |
| K111858 | sano transportgeraete | LIFTKAR PT | November 4, 2011 |
| K103122 | aat alber antriebstechnik | C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION | December 30, 2010 |
| K093946 | hoveround | HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 | March 22, 2010 |
| K091858 | summit harmar | PINNACLE STAIR WAY LIFT | July 1, 2009 |
| K073110 | merits health products co | MERITS E600 SERIES STAIR LIFT | February 6, 2008 |
| K033829 | bruno independent living aids | BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100 | December 29, 2003 |
| K033752 | bruno independent living aids | BRUNO ELECTRA-RIDE STAIRWAY ELEVATOR SYSTEM. MODEL SRE-1540 | December 12, 2003 |
| K033438 | bruno independent living aids | BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000 | November 20, 2003 |
| K032880 | summit lifts | SUMMIT STAIRWAY LIFT | November 10, 2003 |
| K023852 | services industriels savaria | STAIRFRIEND CURVED STAIRWAY CHAIRLIFT | March 4, 2003 |
| K024345 | services industriels savaria | B.07 STAIRWAY CHAIRLIFT | February 26, 2003 |
| K024167 | services industriels savaria | STEP-SAVER STAIRWAY CHAIRLIFT | February 6, 2003 |
| K022509 | bruno independent living aids | BRUNO ELECTRA-RIDE, MODEL SRE-2700 | August 13, 2002 |
| K970927 | bruno independent living aids | BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM | August 26, 1997 |