The following data is part of a premarket notification filed by Lancer Assoc. with the FDA for Girex.
| Device ID | K831033 |
| 510k Number | K831033 |
| Device Name: | GIREX |
| Classification | Exerciser, Non-measuring |
| Applicant | LANCER ASSOC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ION |
| CFR Regulation Number | 890.5370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-31 |
| Decision Date | 1983-04-27 |