The following data is part of a premarket notification filed by Lode Corp. with the FDA for Lode Model Corival Ergometer.
| Device ID | K851097 |
| 510k Number | K851097 |
| Device Name: | LODE MODEL CORIVAL ERGOMETER |
| Classification | Exerciser, Measuring |
| Applicant | LODE CORP. 2121 TERRY AVE. Seattle, WA 98121 |
| Contact | Dan Roper |
| Correspondent | Dan Roper LODE CORP. 2121 TERRY AVE. Seattle, WA 98121 |
| Product Code | ISD |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-19 |
| Decision Date | 1985-06-18 |