The following data is part of a premarket notification filed by Alber Gmbh with the FDA for Smoov O10.
| Device ID | K192016 |
| 510k Number | K192016 |
| Device Name: | SMOOV O10 |
| Classification | Wheelchair, Powered |
| Applicant | Alber GmbH Vor Dem Weißen Stein 21 Albstadt, DE 72461 |
| Contact | Michael Vent |
| Correspondent | Michael Vent Alber GmbH Vor Dem Weißen Stein 21 Albstadt, DE 72461 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-29 |
| Decision Date | 2020-05-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04046727188252 | K192016 | 000 |
| 04046727188245 | K192016 | 000 |