The following data is part of a premarket notification filed by Isotechnologies, Inc. with the FDA for Isostation Lower Back Machine.
| Device ID | K842296 |
| 510k Number | K842296 |
| Device Name: | ISOSTATION LOWER BACK MACHINE |
| Classification | System, Isokinetic Testing And Evaluation |
| Applicant | ISOTECHNOLOGIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IKK |
| CFR Regulation Number | 890.1925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-11 |
| Decision Date | 1984-06-22 |