The following data is part of a premarket notification filed by Medichanics, Inc. with the FDA for Hydra Tred Dc.
| Device ID | K801250 |
| 510k Number | K801250 |
| Device Name: | HYDRA TRED DC |
| Classification | Treadmill, Mechanical |
| Applicant | MEDICHANICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IOG |
| CFR Regulation Number | 890.5370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-28 |
| Decision Date | 1980-06-17 |