Exerciser, Measuring
FDA product code ISD · Class II (moderate risk) · 21 CFR 890.5360 · Physical Medicine
61510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Tri-Tech, Inc. 4
- Quinton, Inc. 4
- Henley Intl. 4
- Biodan Medical Systems, Ltd. 3
- Stanford Scientific, Inc. 3
- Tri W-G, Inc. 2
- Battle Creek Equipment Co. 2
- Th Charters, Inc. 2
- Penny and Giles Biometrics , Ltd. 2
- Ergoline GmbH 2
- Engineering Dynamics Corp. 2
- Amf, Inc. 1
- Lode Corp. 1
- Ketronic, Inc. 1
- 3-D Orthopedic, Inc. 1
- I-Rep, Inc. 1
- Bayshore Systems Corp. 1
- Sears, Roebuck & Co. 1
- Victoreen, Inc. 1
- Lode B.V. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K202979 | MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal…ISD · Abbreviated | Lode B.V. | 12/21/2020SE |
| K183296 | REAL Immersive SystemISD · Traditional | Penumbra, Inc. | 03/18/2019SE |
| K143512 | ActiSpec Activity MonitorISD · Traditional | Sleep Modus, Inc. | 08/26/2015SE |
| K112121 | Ergoselect/GeISD · Traditional | Ergoline GmbH | 10/31/2012SE |
| K080545 | ActitrainerISD · Traditional | Actigraph, LLC | 07/24/2008SE |
| K053078 | Ergoselect 100 K/P, Ergoselect 200 K/PISD · Traditional | Ergoline GmbH | 04/27/2006SE |
| K990866 | Quinton Medtrack CR Plus TreadmillISD · Traditional | Quinton, Inc. | 04/29/1999SE |
| K990813 | RehcorISD · Traditional | Electromed Corp. | 04/12/1999SE |
| K962855 | ULE-2, MULE-2, Hand Accessory KitISD · Traditional | Penny and Giles Biometrics , Ltd. | 12/11/1996SE |
| K952163 | David Back Clinic SystemISD · Traditional | Kinetic Resources, Inc. | 08/12/1996SE |
| K941033 | Physio HabISD · Traditional | Longo Industries | 02/27/1995SE |
| K940065 | SES100ISD · Traditional | Southwest Ergonomics | 12/06/1994SE |
| K934238 | MuleISD · Traditional | Penny and Giles Biometrics , Ltd. | 10/26/1994SE |
| K930735 | Lordex Lumbar Extension MachineISD · Traditional | Lordex, Inc. | 09/29/1994SE |
| K933611 | The Bte WS30ISD · Traditional | Baltimore Therapeutic Equipment Co. | 06/20/1994SE |
| K926279 | Upper Body ExerciserISD · Traditional | Henley Intl. | 05/05/1994SE |
| K926278 | Stair ClimberISD · Traditional | Henley Intl. | 05/05/1994SE |
| K926287 | Exercise BicycleISD · Traditional | Henley Intl. | 03/22/1994SE |
| K926314 | Hydra Fitness Model 311 Total PowerISD · Traditional | Henley Intl. | 03/18/1994SE |
| K930253 | CARDIO2 CtckeISD · Traditional | Ergometrx, Inc. | 10/18/1993SE |
| K926170 | Stepmill Exercise SystemISD · Traditional | Stairmaster Sports/Medical Products, Inc. | 03/31/1993SE |
| K922606 | Multi Joint Weight System Model #940-100ISD · Traditional | Biodan Medical Systems, Ltd. | 06/19/1992SE |
| K922603 | Total Work Integrator, Model #940-110ISD · Traditional | Biodan Medical Systems, Ltd. | 06/19/1992SE |
| K922602 | Cable Column Weight System Model #940-200ISD · Traditional | Biodan Medical Systems, Ltd. | 06/19/1992SE |
| K912140 | Stairmaster Model 6000 ErgometerISD · Traditional | Tri-Tech, Inc. | 12/17/1991SE |
| K912058 | Gauntlet Stair ClimberISD · Traditional | Tri-Tech, Inc. | 10/24/1991SE |
| K912057 | 4000 PT Exercise SystemISD · Traditional | Tri-Tech, Inc. | 10/24/1991SE |
| K912056 | Gravitron Upper Body System ExerciserISD · Traditional | Tri-Tech, Inc. | 10/24/1991SE |
| K912227 | Monark ErgometersISD · Traditional | Quinton, Inc. | 08/07/1991SE |
| K904823 | FlexercycleISD · Traditional | Medmetric Corp. | 01/30/1991SE |
| K894154 | Metabolic SystemsISD · Traditional | Cybex | 10/24/1989SE |
| K890401 | Golden Mean Machine(Tm) (Class 2)ISD · Traditional | Bennett Ergonomic Labs, Inc. | 04/21/1989SE |
| K880032 | Medex MachineISD · Traditional | Medex, Inc. | 02/11/1988SE |
| K880271 | Resubmitted ExcaliburISD · Traditional | Quinton, Inc. | 02/03/1988SE |
| K871494 | Uppercycle Stationary Exercise MachinesISD · Traditional | Engineering Dynamics Corp. | 05/06/1987SE |
| K870872 | Discipline IISD · Traditional | Physio Systems, Inc. | 03/23/1987SE |
| K864581 | ApplidynISD · Traditional | Grandcor Medical Systems | 01/21/1987SE |
| K863884 | Pulsestar Exercise BikeISD · Traditional | Battle Creek Equipment Co. | 10/23/1986SE |
| K861348 | R1361 & R1372 Measured Exercise EquipmentISD · Traditional | Tri W-G, Inc. | 05/02/1986SE |
| K851967 | Torque Feedback MeterISD · Traditional | Th Charters, Inc. | 07/19/1985SE |
| K851946 | Remote Speed ControlISD · Traditional | Th Charters, Inc. | 07/19/1985SE |
| K851097 | Lode Model Corival ErgometerISD · Traditional | Lode Corp. | 06/18/1985SE |
| K850869 | Mfe Couch ErgometerISD · Traditional | Ketronic, Inc. | 06/12/1985SE |
| K843850 | Universal-ErgotestISD · Traditional | Erich Jaeger, Inc. | 11/27/1984SE |
| K834360 | 3-D Passive MobilizerISD · Traditional | 3-D Orthopedic, Inc. | 01/13/1984SE |
| K834098 | Stationary Exercise BicycleISD · Traditional | Engineering Dynamics Corp. | 12/27/1983SE |
| K832940 | RotagymISD · Traditional | I-Rep, Inc. | 11/07/1983SE |
| K801868 | Cal-CountISD · Traditional | Bayshore Systems Corp. | 08/27/1980SE |
| K800939 | Computrim 900ISD · Traditional | Amf, Inc. | 05/28/1980SE |
| K800892 | Nuclear Stress Table (NST-1)ISD · Traditional | Technicare Corp. | 05/14/1980SE |
| K800072 | Digital Electronic Exerciser/Pulse Mtr.ISD · Traditional | Sears, Roebuck & Co. | 01/28/1980SE |
| K792591 | Stress Table/Ergometer SystemISD · Traditional | Victoreen, Inc. | 01/04/1980SE |
| K792121 | Aerobitron IIIISD · Traditional | Stanford Scientific, Inc. | 11/15/1979SE |
| K792120 | Aerobitron IIISD · Traditional | Stanford Scientific, Inc. | 11/15/1979SE |
| K791966 | Aerobitron 1ISD · Traditional | Stanford Scientific, Inc. | 10/17/1979SE |
| K791866 | Standard Health Bike Model 019ISD · Traditional | Battle Creek Equipment Co. | 10/04/1979SE |
| K781997 | AutorangeISD · Traditional | Tri W-G, Inc. | 01/08/1979SE |
| K781889 | Collins Pedalmate 2ISD · Traditional | Warren E. Collins, Inc. | 11/22/1978SE |
| K770234 | Model 880 Rehabilitation TrainerISD · Traditional | Quinton, Inc. | 02/14/1977SE |
| K770148 | Calibrated Grasping TubesISD · Traditional | Maddak, Inc. | 02/01/1977SE |
| K770164 | Finger Muscle TesterISD · Traditional | Bel-Art Products | 01/28/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1986-2015 Class II | Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise…On the Primus that includes the optional Chop / Lift Bar, there is a remote possibility that the Chop / Lift… | BTE Technologies, Inc. | 04/09/2015Terminated |
| Z-0935-2015 Class II | Lumbar Extension Machine for Physical TherapyReview of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these… | MedX Holdings, Inc. | 12/03/2013Terminated |