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 |