Treadmill Model 3060

FDA 510(k) K792661 · Cambridge Instruments, Inc.

Substantially Equivalent

510(k) numberK792661

Submission

Device name
Treadmill Model 3060
Applicant
Cambridge Instruments, Inc.
Mchenry, IL, US
Received
December 26, 1979
Decision date
February 19, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

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)DeviceApplicantDecision
K950377Parker Model PeIOL · Traditional Parker Treadmill Co., Inc.09/06/1995SE
K950376Parker Model PMIOL · Traditional Parker Treadmill Co., Inc.09/06/1995SE
K925839TrackmasterIOL · Traditional Jas Manufacturing Co., Inc.06/24/1993SE
K930261RTM Rehabilitation Treadmill, Model #945-200IOL · Traditional Biodan Medical Systems, Ltd.05/26/1993SE
K904556Mansfield Cardiac Assist Model 940(TM) IabIOL · Traditional Boston Scientific Corp12/18/1991SE
K913518TA620 Treadmill ControllerIOL · Traditional Siemens Burdick, Inc.10/24/1991SE
K910867T600 TreadmillIOL · Traditional Siemens Burdick, Inc.05/31/1991SE
K911751Medtrack TreadmillIOL · Traditional Quinton, Inc.05/29/1991SE
K897179Orbiter(Tm) TreadmillIOL · Traditional Lee-Meredith Industries, Inc.02/15/1990SE
K895104Aquatrex Underwater Treadmill SystemIOL · Traditional Edmonds Medical Systems12/04/1989SE

More from Edmonds Medical Systems

510(k)DeviceDecision
K811121Central Station Monitoring SystemsDPS · Traditional 06/30/1981SE
K811062Campbridge ComputraceDXG · Traditional 05/29/1981SE
K8032294-CHANNEL ECG Telemetry Mon. Syst. #3045DRG · Traditional 01/13/1981SE
K801224Cambridge Cardiac Diagnostic SystemDXK · Traditional 06/26/1980SE
K800566Cambridge VS-550 ElectrocardiographDPS · Traditional 04/08/1980SE
K791201Scintistress SystemDPS · Traditional 09/17/1979SE
K790509Cardiocassette II, Ambulatory ECG SystemDSH · Traditional 03/23/1979SE
K7613183038 Option B-Comput. Trans. TerminalDXH · Traditional 01/06/1977SE
K761198Model 3044 3-CHANNEL Stress Test SystemDPS · Traditional 12/09/1976SE
K760926Electrocardiograph (Model VS-4B)DPS · Traditional 11/09/1976SE

Questions and answers

When was Treadmill Model 3060 cleared by the FDA?

Treadmill Model 3060 (K792661) received a 510(k) decision of Substantially Equivalent on February 19, 1980, 55 days after the submission was received.

What is the product code of K792661?

The FDA product code is IOL – Treadmill, Powered, a Class I (low risk) device regulated under 21 CFR 890.5380.