The following data is part of a premarket notification filed by Levo Ag with the FDA for Levo Comfort Ii.
| Device ID | K051387 |
| 510k Number | K051387 |
| Device Name: | LEVO COMFORT II |
| Classification | Wheelchair, Standup |
| Applicant | LEVO AG ANGLIKERSTRASSE 20 P.O. BOX 1272 Wohlen, CH Ch-5610 |
| Contact | Markus Burger |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | IPL |
| CFR Regulation Number | 890.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-05-27 |
| Decision Date | 2005-06-10 |
| Summary: | summary |