Treadmill, Powered
FDA product code IOL · Class I (low risk) · 21 CFR 890.5380 · Physical Medicine
43510(k) clearances
0PMA approvals
19recalls
Manufacturers
- Quinton, Inc. 9
- Eaton Medical Group 3
- Burdick Corp. 3
- Battle Creek Equipment Co. 3
- Erich Jaeger, Inc. 2
- Parker Treadmill Co., Inc. 2
- Siemens Burdick, Inc. 2
- Structural Analysis Systems, Inc. 2
- Physio-Control Corp. 2
- Ogden Health Products 1
- Medasonics, Inc. 1
- Marquette Electronics, Inc. 1
- Del Mar Avionics 1
- Cambridge Instruments, Inc. 1
- Cambridge Medical Instruments, Inc. 1
- Tri W-G, Inc. 1
- Unisen, Inc. 1
- Pacer Industries, Inc. 1
- Edmonds Medical Systems 1
- Lee-Meredith Industries, Inc. 1
510(k) clearances
| 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 |
| K893032 | Pacer R 9 TreadmillIOL · Traditional | Pacer Industries, Inc. | 07/27/1989SE |
| K890793 | StartracIOL · Traditional | Unisen, Inc. | 03/16/1989SE |
| K885062 | Modified Q-Series of TreadmillsIOL · Traditional | Quinton, Inc. | 12/27/1988SE |
| K864013 | Model Q55XT Powered TreadmillIOL · Traditional | Quinton, Inc. | 11/14/1986SE |
| K863299 | Modified Q50 Medical TreadmillIOL · Traditional | Quinton, Inc. | 09/09/1986SE |
| K862741 | Q50 Medical TreadmillIOL · Traditional | Quinton, Inc. | 07/29/1986SE |
| K861347 | R1596 Powered Exercise EquipmentIOL · Traditional | Tri W-G, Inc. | 05/02/1986SE |
| K854147 | Battle Creek Boardwalker Electric TreadmillIOL · Traditional | Battle Creek Equipment Co. | 12/27/1985SE |
| K854148 | Battle Creek Digi-Tracker Elctric TreadmillIOL · Traditional | Battle Creek Equipment Co. | 12/17/1985SE |
| K854283 | Cambridge Model XT1000IOL · Traditional | Cambridge Medical Instruments, Inc. | 11/13/1985SE |
| K851631 | TMX-C1/C2 Tradmill Controller Access.IOL · Traditional | Eaton Medical Group | 07/15/1985SE |
| K851630 | TMX-80 TreadmillIOL · Traditional | Eaton Medical Group | 07/09/1985SE |
| K851629 | TMX-70 TreadmillIOL · Traditional | Eaton Medical Group | 07/09/1985SE |
| K850044 | Treadmill E-17IOL · Traditional | Del Mar Avionics | 04/04/1985SE |
| K843859 | Lauf-Ergotest JuniorIOL · Traditional | Erich Jaeger, Inc. | 11/27/1984SE |
| K843853 | Lauf-ErgotestIOL · Traditional | Erich Jaeger, Inc. | 11/27/1984SE |
| K840280 | Road Runner Electric TreadmillIOL · Traditional | Battle Creek Equipment Co. | 02/04/1984SE |
| K833588 | Vascular Laboratory Treadmill VT1IOL · Traditional | Medasonics, Inc. | 11/14/1983SE |
| K830146 | Program. Treadmill Controller #645IOL · Traditional | Quinton, Inc. | 02/02/1983SE |
| K823003 | Q65 Medical TreadmillIOL · Traditional | Quinton, Inc. | 10/27/1982SE |
| K820548 | Powered TreadmillIOL · Traditional | Ogden Health Products | 03/15/1982SE |
| K820478 | Quinton Q55 Medical TreadmillIOL · Traditional | Quinton, Inc. | 03/11/1982SE |
| K813486 | Teletred Gait Analysis SystemIOL · Traditional | Structural Analysis Systems, Inc. | 01/29/1982SE |
| K813485 | SAS Educational ChartIOL · Traditional | Structural Analysis Systems, Inc. | 01/29/1982SE |
| K802836 | Series 1800 Exercise TreadmillIOL · Traditional | Marquette Electronics, Inc. | 12/11/1980SE |
| K792661 | Treadmill Model 3060IOL · Traditional | Cambridge Instruments, Inc. | 02/19/1980SE |
| K792590 | AP-1 Auto ProgrammerIOL · Traditional | Burdick Corp. | 01/04/1980SE |
| K771697 | Cardio-Exercise Treadmill 550IOL · Traditional | Quinton, Inc. | 09/20/1977SE |
| K770240 | Treadmill Stress Exercise SystemIOL · Traditional | Burdick Corp. | 02/14/1977SE |
| K761041 | Powered Treadmill (30/ST)IOL · Traditional | Physio-Control Corp. | 12/09/1976SE |
| K761040 | Powered Treadmill (20/ST)IOL · Traditional | Physio-Control Corp. | 12/09/1976SE |
| K760509 | Treadmill, DiagnosticIOL · Traditional | Medcraft Corp. | 08/30/1976SE |
| K760275 | Treadmill (TMS-300)IOL · Traditional | Burdick Corp. | 08/11/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2058-2023 Class II | TRACKMASTER, TREADMILL GE T2100-ST2 220V CHINA, MODEL NUMBER 317-07927GE CHINATreadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. | Full Vision Inc | 05/12/2023Open, Classified |
| Z-2057-2023 Class II | TRACKMASTER, TREADMILL GE T2100-ST2 220V, MODEL NUMBER 317-07927GETreadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. | Full Vision Inc | 05/12/2023Open, Classified |
| Z-2056-2023 Class II | TRACKMASTER, TREADMILL GE T2100-ST1 110VV, MODEL NUMBER 317-07926GETreadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. | Full Vision Inc | 05/12/2023Open, Classified |
| Z-2055-2023 Class II | TRACKMASTER, TREADMILL TMX428CP 220V, MODEL NUMBER 317-07929Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. | Full Vision Inc | 05/12/2023Open, Classified |
| Z-2054-2023 Class II | TRACKMASTER, TREADMILL TMX428CP 110V, MODEL NUMBER 317-07928Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. | Full Vision Inc | 05/12/2023Open, Classified |
| Z-2053-2023 Class II | TRACKMASTER, TREADMILL TMX428 220V, MODEL NUMBER 317-07927Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. | Full Vision Inc | 05/12/2023Open, Classified |
| Z-2052-2023 Class II | TRACKMASTER, TREADMILL TMX428 110V, MODEL NUMBER 317-07926Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. | Full Vision Inc | 05/12/2023Open, Classified |
| Z-0370-2023 Class II | FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST2 220V, Model #317-07927GE CHINAThis has been identified a rare occurrence, under a specific scenario, where the circuit is found in a… | Full Vision Inc | 08/31/2022Open, Classified |
| Z-0369-2023 Class II | FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST2 220V, Model #317-07927GEThis has been identified a rare occurrence, under a specific scenario, where the circuit is found in a… | Full Vision Inc | 08/31/2022Open, Classified |
| Z-0368-2023 Class II | FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST1 110V, Model #317-07926GEThis has been identified a rare occurrence, under a specific scenario, where the circuit is found in a… | Full Vision Inc | 08/31/2022Open, Classified |
| Z-0367-2023 Class II | FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 220V, Model #317-07929This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a… | Full Vision Inc | 08/31/2022Open, Classified |
| Z-0366-2023 Class II | FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 110V, Model #317-07928This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a… | Full Vision Inc | 08/31/2022Open, Classified |
| Z-0365-2023 Class II | FULL VISION INC. TRACKMASTER,TREADMILL TMX428 220V, Model #317-07927This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a… | Full Vision Inc | 08/31/2022Open, Classified |
| Z-0364-2023 Class II | FULL VISION INC. TRACKMASTER, TREADMILL TMX428 110V, Model #317-07926This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a… | Full Vision Inc | 08/31/2022Open, Classified |
| Z-2467-2018 Class II | T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment…A performance issue with customer owned spare parts, T2100 Microflex drive (2026182-002 or 2026182-004), was… | GE Medical Systems Ultrasound & Primary… | 04/02/2018Terminated |
| Z-1825-2015 Class II | GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood…GE Healthcare has recently become aware of a potential safety issue due to uncontrolled motion of the… | GE Healthcare | 03/12/2015Terminated |
| Z-1285-2015 Class II | GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers…Potential safety issue due to improper assembly associated with the power cords of T2100 and T2000 Treadmills. | GE Healthcare | 02/16/2015Terminated |
| Z-1131-2014 Class II | Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity…Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are… | AlterG, Incorporated | 01/28/2014Terminated |
| Z-1757-2010 | Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac…28 stress and rehab treadmills manufactured between September 2006 and January 2009 may not have received… | Cardiac Science Corporation | 03/30/2009Terminated |