510(k) K121561
K121561 is an FDA 510(k) premarket notification submitted by Thyssenkrupp Accessibility B.V. for the device "FLOW2, SWING". The FDA issued a decision of Substantially Equivalent on October 26, 2012. The device falls under product code ILK (Transport, Patient, Powered), a Class II device regulated under 21 CFR 890.5150. Thyssenkrupp Accessibility B.V. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 2012
- Date Received
- May 29, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transport, Patient, Powered
- Device Class
- Class II
- Regulation Number
- 890.5150
- Review Panel
- PM
- Submission Type
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.