The following data is part of a premarket notification filed by Everest & Jennings, Inc. with the FDA for Ellipse 2.3.
| Device ID | K905621 |
| 510k Number | K905621 |
| Device Name: | ELLIPSE 2.3 |
| Classification | Wheelchair, Mechanical |
| Applicant | EVEREST & JENNINGS, INC. 3233 E MISSION OAKS BLVD. Camarillo, CA 93010 |
| Contact | Jackie Wilkins |
| Correspondent | Jackie Wilkins EVEREST & JENNINGS, INC. 3233 E MISSION OAKS BLVD. Camarillo, CA 93010 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-14 |
| Decision Date | 1990-12-21 |