Program. Treadmill Controller #645
FDA 510(k) K830146 · Quinton, Inc.
510(k) numberK830146
Submission
- Device name
- Program. Treadmill Controller #645
- Applicant
- Quinton, Inc.
Mchenry, IL, US - Received
- January 17, 1983
- Decision date
- February 2, 1983
- 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 |
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| K003576 | Q-Tel RMS (Rehabilitation Management System), Model 000503DSI · Abbreviated | 01/25/2001SE |
| K001492 | Quinton Q-Stress, Model 000483DPS · Abbreviated | 08/09/2000SE |
| K992908 | Q-Tel Telemetry System V. 6.0 (ST)DSI · Traditional | 03/06/2000SE |
| K990866 | Quinton Medtrack CR Plus TreadmillISD · Traditional | 04/29/1999SE |
| K971397 | Viewcath 3-D Catheter PullbackITX · Traditional | 08/25/1997SE |
| K964784 | Synergy Cardiology Information System (00431)DPS · Traditional | 08/13/1997SE |
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Questions and answers
When was Program. Treadmill Controller #645 cleared by the FDA?
Program. Treadmill Controller #645 (K830146) received a 510(k) decision of Substantially Equivalent on February 2, 1983, 16 days after the submission was received.
What is the product code of K830146?
The FDA product code is IOL – Treadmill, Powered, a Class I (low risk) device regulated under 21 CFR 890.5380.