FLOW2, Swing
FDA 510(k) K121561 · Thyssenkrupp Accessibility B.V.
510(k) numberK121561
Submission
- Device name
- FLOW2, Swing
- Applicant
- Thyssenkrupp Accessibility B.V.
Zuid-Holland, NL - Received
- May 29, 2012
- Decision date
- October 26, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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.
Other 510(k)s with product code ILK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K073110 | Merits E600 Series Stair LiftILK · Traditional | Merits Health Products Co., Ltd. | 02/06/2008SE |
More from Merits Health Products Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K121560 | Levant, HomeglideILK · Traditional | 11/01/2012SE |
Questions and answers
When was FLOW2, Swing cleared by the FDA?
FLOW2, Swing (K121561) received a 510(k) decision of Substantially Equivalent on October 26, 2012, 150 days after the submission was received.
What is the product code of K121561?
The FDA product code is ILK – Transport, Patient, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5150.