The following data is part of a premarket notification filed by Lumex, Inc. with the FDA for Mechanical Wheelchair 890.3850.
| Device ID | K945175 |
| 510k Number | K945175 |
| Device Name: | MECHANICAL WHEELCHAIR 890.3850 |
| Classification | Wheelchair, Mechanical |
| Applicant | LUMEX, INC. 100 SPENCE ST. Bay Shore, NY 11706 -2290 |
| Contact | James P Difalco |
| Correspondent | James P Difalco LUMEX, INC. 100 SPENCE ST. Bay Shore, NY 11706 -2290 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-21 |
| Decision Date | 1995-05-12 |