The following data is part of a premarket notification filed by Alber Gmbh with the FDA for Twion.
Device ID | K151717 |
510k Number | K151717 |
Device Name: | Twion |
Classification | Wheelchair, Powered |
Applicant | Alber GmbH Vor Dem Weissen Stein 21 Albstadt, DE D72461 |
Contact | Bernd Engels |
Correspondent | Susan Goldstein-falk MDI CONSULTANTS, INC 55 NORTHERN BLVD. STE 200 Great Neck, NY 11021 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-06-25 |
Decision Date | 2016-02-23 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() TWION 85838156 4509162 Live/Registered |
ULRICH ALBER GmbH 2013-02-01 |