The following data is part of a premarket notification filed by Lordex, Inc. with the FDA for Lordex Lumbar Extension Machine.
| Device ID | K930735 |
| 510k Number | K930735 |
| Device Name: | LORDEX LUMBAR EXTENSION MACHINE |
| Classification | Exerciser, Measuring |
| Applicant | LORDEX, INC. 10044 ADAMS AVE. SUITE 218 HUNTINGTON BEACH, CA 92646 |
| Contact | ANITA THIBEAULT |
| Correspondent | ANITA THIBEAULT LORDEX, INC. 10044 ADAMS AVE. SUITE 218 HUNTINGTON BEACH, CA 92646 |
| Product Code | ISD |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-11 |
| Decision Date | 1994-09-29 |