Bruno Electra-Ride Stair-Way Elevator System
FDA 510(k) K921648 · Bruno Independent Living Aids, Inc.
510(k) numberK921648
Submission
- Device name
- Bruno Electra-Ride Stair-Way Elevator System
- Applicant
- Bruno Independent Living Aids, Inc.
Oconomowoc, WI, US - Received
- April 6, 1992
- Decision date
- May 4, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ILK – Transport, Patient, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5150
- Specialty
- Physical Medicine
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.
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| K240843 | Genesis (MS-P02-GEN)ILK · Traditional | Climbing Steps, Inc. | 10/07/2024SE |
| K222818 | Xpedition Powered Stair Chair (625700000000)ILK · Traditional | Stryker Medical | 01/24/2023SE |
| K130864 | C-Max+ (Plus)ILK · Traditional | Aat Alber Antriebstechnik GmbH | 02/06/2014SE |
| K121560 | Levant, HomeglideILK · Traditional | Thyssenkrupp Accessibility B.V. | 11/01/2012SE |
| K121561 | FLOW2, SwingILK · Traditional | Thyssenkrupp Accessibility B.V. | 10/26/2012SE |
| K113308 | Bruno Elan Stairway ElevatorILK · Special | Bruno Independent Living Aids, Inc. | 02/01/2012SE |
| K111858 | Liftkar PTILK · Traditional | Sano Transportgeraete GmbH | 11/04/2011SE |
| K103122 | C-Max, C-Max U1, C-Max U1 160KG, C-Max U2, C-Max U2 160KG, S-Max, S-Max Aviation, S-Max…ILK · Traditional | Aat Alber Antriebstechnik GmbH | 12/30/2010SE |
| K093946 | Hoveround Hoverglide Model Hoverglide MK-2ILK · Traditional | Hoveround Corp. | 03/22/2010SE |
| K091858 | Pinnacle Stair Way LiftILK · Traditional | Summit Harmar, LLC | 07/01/2009SE |
More from Summit Harmar, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K113308 | Bruno Elan Stairway ElevatorILK · Special | 02/01/2012SE |
| K061514 | Bruno Vertical Platform Lift, Model VPL-3100ING · Traditional | 07/13/2006SE |
| K033829 | Bruno Electra-Ride III Stairway Elevator System, Model CRE-2100ILK · Special | 12/29/2003SE |
| K033752 | Bruno Electra-Ride Stairway Elevator System. Model SRE-1540ILK · Special | 12/12/2003SE |
| K033438 | Bruno Electra-Ride Elite, Model SRE-2000ILK · Special | 11/20/2003SE |
| K022509 | Bruno Electra-Ride, Model SRE-2700ILK · Special | 08/13/2002SE |
| K011227 | Regal Mototrized 3 Wheeled VehicleITI · Special | 05/11/2001SE |
| K002205 | CaronyIOR · Abbreviated | 08/10/2000SE |
| K991954 | The Bruno Powerbase, Model PSB-2200ITI · Traditional | 11/02/1999SE |
| K970927 | Bruno Electra-Ride III Stairway Elevator SystemILK · Traditional | 08/26/1997SE |
Questions and answers
When was Bruno Electra-Ride Stair-Way Elevator System cleared by the FDA?
Bruno Electra-Ride Stair-Way Elevator System (K921648) received a 510(k) decision of Substantially Equivalent on May 4, 1992, 28 days after the submission was received.
What is the product code of K921648?
The FDA product code is ILK – Transport, Patient, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5150.