The following data is part of a premarket notification filed by Eaton Medical Group with the FDA for Tmx-c1/c2 Tradmill Controller Access..
| Device ID | K851631 |
| 510k Number | K851631 |
| Device Name: | TMX-C1/C2 TRADMILL CONTROLLER ACCESS. |
| Classification | Treadmill, Powered |
| Applicant | EATON MEDICAL GROUP P.O. BOX 276 Eaton, MI |
| Contact | Paul P Kluwe |
| Correspondent | Paul P Kluwe EATON MEDICAL GROUP P.O. BOX 276 Eaton, MI |
| Product Code | IOL |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-18 |
| Decision Date | 1985-07-15 |