The following data is part of a premarket notification filed by Alber Gmbh with the FDA for E-motion M25.
Device ID | K192618 |
510k Number | K192618 |
Device Name: | E-Motion M25 |
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 | 2019-09-23 |
Decision Date | 2020-11-02 |
Summary: | summary |