The following data is part of a premarket notification filed by Thyssenkrupp Accessibility B.v. with the FDA for Flow2, Swing.
| Device ID | K121561 |
| 510k Number | K121561 |
| Device Name: | FLOW2, SWING |
| Classification | Transport, Patient, Powered |
| Applicant | THYSSENKRUPP ACCESSIBILITY B.V. VAN UTRECHTWEG 99 KRIMPEN AAN DEN IJSSEL Zuid-holland, NL 2921 Ln |
| Contact | Arnold Heiden |
| Correspondent | Arnold Heiden THYSSENKRUPP ACCESSIBILITY B.V. VAN UTRECHTWEG 99 KRIMPEN AAN DEN IJSSEL Zuid-holland, NL 2921 Ln |
| Product Code | ILK |
| CFR Regulation Number | 890.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-29 |
| Decision Date | 2012-10-26 |
| Summary: | summary |