K121561 is an FDA 510(k) clearance for the FLOW2, SWING. This device is classified as a Transport, Patient, Powered (Class II - Special Controls, product code ILK).
Submitted by Thyssenkrupp Accessibility B.V. (Zuid-Holland, NL). The FDA issued a Cleared decision on October 26, 2012, 150 days after receiving the submission on May 29, 2012.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5150. 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..
| 510(k) Number | K121561 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2012 |
| Decision Date | October 26, 2012 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ILK — Transport, Patient, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5150 |
| 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. |