TMX-80 Treadmill
FDA 510(k) K851630 · Eaton Medical Group
510(k) numberK851630
Submission
- Device name
- TMX-80 Treadmill
- Applicant
- Eaton Medical Group
Eaton, MI, US - Received
- April 18, 1985
- Decision date
- July 9, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IOL – Treadmill, Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5380
- Specialty
- Physical Medicine
Other 510(k)s with product code IOL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950377 | Parker Model PeIOL · Traditional | Parker Treadmill Co., Inc. | 09/06/1995SE |
| K950376 | Parker Model PMIOL · Traditional | Parker Treadmill Co., Inc. | 09/06/1995SE |
| K925839 | TrackmasterIOL · Traditional | Jas Manufacturing Co., Inc. | 06/24/1993SE |
| K930261 | RTM Rehabilitation Treadmill, Model #945-200IOL · Traditional | Biodan Medical Systems, Ltd. | 05/26/1993SE |
| K904556 | Mansfield Cardiac Assist Model 940(TM) IabIOL · Traditional | Boston Scientific Corp | 12/18/1991SE |
| K913518 | TA620 Treadmill ControllerIOL · Traditional | Siemens Burdick, Inc. | 10/24/1991SE |
| K910867 | T600 TreadmillIOL · Traditional | Siemens Burdick, Inc. | 05/31/1991SE |
| K911751 | Medtrack TreadmillIOL · Traditional | Quinton, Inc. | 05/29/1991SE |
| K897179 | Orbiter(Tm) TreadmillIOL · Traditional | Lee-Meredith Industries, Inc. | 02/15/1990SE |
| K895104 | Aquatrex Underwater Treadmill SystemIOL · Traditional | Edmonds Medical Systems | 12/04/1989SE |
More from Edmonds Medical Systems
| 510(k) | Device | Decision |
|---|---|---|
| K851623 | Model TRC-40 Telemetry Reciever ModuleDXH · Traditional | 01/22/1986SE |
| K851624 | Model TT-185 Telemetry TransmitterDXH · Traditional | 01/14/1986SE |
| K851625 | SCX-10 Single Channel Recorder Access. for G-2000DSF · Traditional | 11/19/1985SE |
| K851632 | PCX-100 Patient Input LeadwireDRW · Traditional | 11/08/1985SE |
| K851627 | KBX-20 Outboard Keyboard Access. for G-2000 ElectrDRW · Traditional | 11/08/1985SE |
| K851631 | TMX-C1/C2 Tradmill Controller Access.IOL · Traditional | 07/15/1985SE |
| K851629 | TMX-70 TreadmillIOL · Traditional | 07/09/1985SE |
| K851628 | RMG-9 9 Remote Monitor Access. for G-2000 ElectroDXJ · Traditional | 06/27/1985SE |
| K851633 | CC-100 Clock/Calander Module Access. for G-2000 ElDPS · Traditional | 06/26/1985SE |
| K851626 | SCX-35 Three Channel Access. for Module G-2000 EleDSF · Traditional | 06/26/1985SE |
Questions and answers
When was TMX-80 Treadmill cleared by the FDA?
TMX-80 Treadmill (K851630) received a 510(k) decision of Substantially Equivalent on July 9, 1985, 82 days after the submission was received.
What is the product code of K851630?
The FDA product code is IOL – Treadmill, Powered, a Class I (low risk) device regulated under 21 CFR 890.5380.