The following data is part of a premarket notification filed by Ulrich Alber Gmbh & Co. with the FDA for E Motion Wheelchair Drive System (power-assist For Manual Wheelchairs).
| Device ID | K003449 |
| 510k Number | K003449 |
| Device Name: | E MOTION WHEELCHAIR DRIVE SYSTEM (POWER-ASSIST FOR MANUAL WHEELCHAIRS) |
| Classification | Wheelchair, Powered |
| Applicant | ULRICH ALBER GMBH & CO. 55 NORTHERN BLVD. Great Neck, NY 12020 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk ULRICH ALBER GMBH & CO. 55 NORTHERN BLVD. Great Neck, NY 12020 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-07 |
| Decision Date | 2001-03-16 |