The following data is part of a premarket notification filed by Ulrich Alber Gmbh with the FDA for Adventure A10.
Device ID | K042535 |
510k Number | K042535 |
Device Name: | ADVENTURE A10 |
Classification | Wheelchair, Powered |
Applicant | ULRICH ALBER GMBH VOR DEM WEISSEN STEIN 21 Albstadt-tailfingen, DE D-72464 |
Contact | Ralf Ledda |
Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2004-09-20 |
Decision Date | 2004-10-05 |
Summary: | summary |