The following data is part of a premarket notification filed by Alber Gmbh with the FDA for E-fix E35/e36.
| Device ID | K161241 |
| 510k Number | K161241 |
| Device Name: | E-fix E35/E36 |
| Classification | Wheelchair, Powered |
| Applicant | Alber GmbH Vor Dem Weissen Stein 21 Albstadt, DE 72461 |
| Contact | Michael Vent |
| Correspondent | Michael Vent BEO MEDCONSULTING BERLIN GMBH HELMHOLTZSTR. 2-9 Berlin, DE 10587 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-02 |
| Decision Date | 2016-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04046727217266 | K161241 | 000 |
| 04046727216900 | K161241 | 000 |
| 04046727216917 | K161241 | 000 |
| 04046727216924 | K161241 | 000 |
| 04046727216931 | K161241 | 000 |
| 04046727216948 | K161241 | 000 |
| 04046727216955 | K161241 | 000 |
| 04046727216962 | K161241 | 000 |
| 04046727216979 | K161241 | 000 |
| 04046727216986 | K161241 | 000 |
| 04046727216993 | K161241 | 000 |
| 04046727217006 | K161241 | 000 |
| 04046727216894 | K161241 | 000 |