The following data is part of a premarket notification filed by Lumex, Inc. with the FDA for Lumex Wheelchairs (ser. 1000, 3000, 4000, 5000, Tilt-in-space, 6000, Mri).
| Device ID | K944574 |
| 510k Number | K944574 |
| Device Name: | LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI) |
| Classification | Wheelchair, Mechanical |
| Applicant | LUMEX, INC. 100 SPENCE ST. Bay Shore, NY 11706 -2290 |
| Contact | James Difalco |
| Correspondent | James 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 | 1994-09-19 |
| Decision Date | 1994-10-17 |