The following data is part of a premarket notification filed by Aat Alber Antriebstechnik Gmbh with the FDA for Powered Wheelchair.
Device ID | K142770 |
510k Number | K142770 |
Device Name: | Powered Wheelchair |
Classification | Wheelchair, Powered |
Applicant | AAT ALBER ANTRIEBSTECHNIK GMBH EHESTETTER WEG 11 Albstadt-ebingen, DE D-72458 |
Contact | Mrs.stefanie D Bankston |
Correspondent | Mrs.stefanie D Bankston BEO MedConsulting Berlin GmbH 3001 Ferndale Dr League City, TX 77573 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-25 |
Decision Date | 2015-06-09 |
Summary: | summary |