The following data is part of a premarket notification filed by Levo Ag with the FDA for Levo Max.
Device ID | K140706 |
510k Number | K140706 |
Device Name: | LEVO MAX |
Classification | Wheelchair, Powered |
Applicant | LEVO AG ANGLIKERSTRASSE 20 5610 Wohlen, CH Ch-5610 |
Contact | Matt Grow |
Correspondent | Paul Holtan LEVO AG ANGLIKERSTRASSE 20 5610 Wohlen, CH Ch-5610 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-03-21 |
Decision Date | 2015-01-21 |
Summary: | summary |