Exerciser, Powered
FDA product code BXB · Class I (low risk) · 21 CFR 890.5380 · Physical Medicine
160510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Allied Associates, Inc. 9
- Toronto Medical Corp. 9
- Buckman Co., Inc. 8
- Invacare Corp. 8
- Sutter Corp. 5
- Sutter Biomedical, Inc. 4
- Dyna Flex, Intl. 4
- Jace Systems, Inc. 3
- Richards Medical Co., Inc. 3
- Biodex Medical Systems, Inc. 3
- Baltimore Therapeutic Equipment Co. 3
- Thera Kinetics, Inc. 3
- Danninger Medical Technology, Inc. 3
- Orthopedic Development, Inc. 2
- Tri W-G, Inc. 2
- Biodynamic Technologies, Inc. 2
- Joint Mobilizer Systems, Inc. 2
- Rehabilitative Resources, Inc. 2
- Richard'S Medical Equip., Inc. 2
- Cropper Medical, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K072887 | G-Trainer MedicalBXB · Traditional | Alter-G, Inc. | 01/25/2008SE |
| K003272 | Flo-BootBXB · Traditional | Discovery Group, LLC | 04/04/2001SE |
| K952975 | Ankle Calf Exerciser PhlebopumpBXB · Traditional | Prevent Products, Inc. | 09/25/1996SE |
| K953456 | E-Z FlexBXB · Traditional | Fluid Motion Biotechnologies, Inc. | 01/26/1996SE |
| K955106 | Bte CPM-20BXB · Traditional | Baltimore Therapeutic Equipment Co. | 12/29/1995SE |
| K955105 | Bte CPM-10BXB · Traditional | Baltimore Therapeutic Equipment Co. | 12/29/1995SE |
| K951028 | Hamex TwoBXB · Traditional | Northern Orthopaedic Products, Inc. | 12/11/1995SE |
| K950755 | Flexmate K500BXB · Traditional | Breg, Inc. | 10/05/1995SE |
| K951029 | Hamex OneBXB · Traditional | Northern Orthopaedic Products, Inc. | 09/15/1995SE |
| K945733 | Aquahab, Model 120-72-101BXB · Traditional | Aquarius Electronics, Inc. | 09/15/1995SE |
| K950682 | W2 Wrist CPM UnitBXB · Traditional | Toronto Medical Corp. | 09/13/1995SE |
| K952369 | KRD PL 2000 Controlled Passive Motion (CPM) PortableBXB · Traditional | Physicians Consulting, Inc. | 08/07/1995SE |
| K945690 | Backcycler Cpm(Tm)BXB · Traditional | Ergomedics, Inc. | 06/22/1995SE |
| K946169 | Actic 2002BXB · Traditional | North Atlantic Rehabilitation, Inc. | 06/15/1995SE |
| K945824 | Galaxy MD Series TherapypoolsBXB · Traditional | Galaxy Aquatics, Inc. | 04/05/1995SE |
| K944819 | KRDL 2000BXB · Traditional | Physicians Consulting, Inc. | 03/10/1995SE |
| K945221 | Sutter Model 6000 Hand CPM DeviceBXB · Traditional | Sutter Corp. | 02/27/1995SE |
| K945121 | A3 Ankle CPM UnitBXB · Traditional | Toronto Medical, Inc. | 02/17/1995SE |
| K940455 | Lateral Flexion MachineBXB · Traditional | Rehab, Inc. | 01/12/1995SN |
| K935011 | Swimex Multidepth Pool (Model 600T)BXB · Traditional | Swimex Systems | 01/09/1995SE |
| K935587 | Multilink Shoulder CPM UnitBXB · Traditional | Toronto Medical Corp. | 12/14/1994SE |
| K935509 | HydrotrackBXB · Traditional | Ferno Ille | 10/03/1994SE |
| K935520 | Upper Body Cycles (110 VOLT)/(220 Volt)BXB · Traditional | Biodex Medical Systems, Inc. | 09/16/1994SE |
| K935216 | Semi-Recumbent CyclesBXB · Traditional | Biodex Medical Systems, Inc. | 09/16/1994SE |
| K935061 | Lower Body CyclesBXB · Traditional | Biodex Medical Systems, Inc. | 09/16/1994SE |
| K942618 | Ankle Calf ExerciserBXB · Traditional | Prevent Products, Inc. | 06/22/1994SE |
| K933059 | Artromot-E, Elbow / Artromot-S, Shoulder CMP Mod.BXB · Traditional | Jace Systems, Inc. | 06/22/1994SE |
| K926136 | WatsystemBXB · Traditional | Watsystem Div. of Itc | 05/20/1994SE |
| K931128 | Basic Shoulder CPMBXB · Traditional | Danninger Medical Technology, Inc. | 05/06/1994SE |
| K935467 | R & D Batteries, Inc. Part Number 5447BXB · Traditional | R & D Batteries, Inc. | 04/19/1994SE |
| K935188 | StretchpowerBXB · Traditional | Orthopedic Development, Inc. | 03/24/1994SE |
| K934175 | Stretchpower(Tm) Brand of Stretch Loading ExerciserBXB · Traditional | Orthopedic Development, Inc. | 03/24/1994SE |
| K935808 | Revolution Lower Limb CPM UnitBXB · Traditional | Toronto Medical, Inc. | 03/18/1994SE |
| K933394 | Danniflex CPM 600BXB · Traditional | Danninger Medical Technology, Inc. | 03/11/1994SE |
| K930780 | ADV400 Toe CPMBXB · Traditional | Advanced Kinetics, Inc. | 02/17/1994SE |
| K926313 | Computerized Testing and Exercise SystemsBXB · Traditional | Henley Intl. | 02/04/1994SE |
| K931555 | Artromot K2 CPMBXB · Traditional | Ormed Mfg., Inc. | 01/31/1994SE |
| K931736 | M-Flex 5000 C3PMDBXB · Traditional | Medical Systems Corp. | 01/27/1994SE |
| K933311 | Motorized Electric Parallel BarsBXB · Traditional | Midland Mfg. Co. | 01/26/1994SE |
| K931723 | Hydro-Tred/Air Powered TreadmillBXB · Traditional | Santa FE Swim Systems | 01/26/1994SE |
| K926262 | First MPJ Continuous Passive Motion DeviceBXB · Traditional | Sgarlato Laboratories, Inc. | 01/26/1994SE |
| K925270 | Ex N' Flex EF-200BXB · Traditional | Tecogics Scientific , Ltd. | 07/21/1993SE |
| K925977 | Paramed Flexion-Extension MachineBXB · Traditional | Paramed Services, Inc. | 03/31/1993SE |
| K925271 | Repex-Repeated Endrange Passive Exercise MachineBXB · Traditional | Repex Intl., Inc. | 03/31/1993SE |
| K924513 | Lido(R) LineaBXB · Traditional | Loredan Biomedical, Inc. | 03/31/1993SE |
| K925807 | Aquaciser In-Pool TreadmillBXB · Traditional | Aquaciser, Inc. | 03/24/1993SE |
| K925926 | Mobilimb T1 Toe CPM UnitBXB · Traditional | Toronto Medical Corp. | 03/22/1993SE |
| K924484 | Artromot Multi Directional Ankle CPMBXB · Traditional | Buckman Co., Inc. | 03/22/1993SE |
| K925666 | Therapacer 3000BXB · Traditional | Kvm Technologies, Inc. | 03/09/1993SE |
| K924654 | First Metatarsophalangeal Joint Motion SplintBXB · Traditional | Sutter Corp. | 02/22/1993SE |
| K925043 | Elbow CPM OrthosisBXB · Traditional | Electrobionics Corp. | 02/12/1993SE |
| K923857 | Artromot SB Elbow AttachmentBXB · Traditional | Buckman Co., Inc. | 02/12/1993SE |
| K923805 | Power PillowBXB · Traditional | Nova Teknic, Inc. | 02/12/1993SE |
| K923494 | Paramed Lateral Flexion MachineBXB · Traditional | Paramed Div | 11/09/1992SE |
| K921348 | Oic Model J4 TMJ CPMBXB · Traditional | Lm Product Design, Inc. | 08/05/1992SE |
| K923217 | Danniflex CPM 2000BXB · Traditional | Buckman Co., Inc. | 08/03/1992SE |
| K923216 | Danninflex CPM 800BXB · Traditional | Buckman Co., Inc. | 08/03/1992SE |
| K922493 | American Medical Mfg. Lumbar CPMBXB · Traditional | American Medical Corp. | 07/27/1992SE |
| K922185 | Jace Knee Extension System -- ModificationBXB · Traditional | Jace Systems, Inc. | 06/11/1992SE |
| K920686 | Ortho-Plex-Rehabilitation SystemBXB · Traditional | Plexus Intl., Inc. | 06/11/1992SE |
| K921323 | Cervical Passive MotionBXB · Traditional | Rehabilitative Resources, Inc. | 06/03/1992SE |
| K920860 | Controlled Passive Motion MachineBXB · Traditional | U.S. Mfg. & Management, Inc. | 04/02/1992SE |
| K920519 | Lumbar CPMBXB · Traditional | Rehabilitative Resources, Inc. | 03/13/1992SE |
| K920270 | Continuous Passive Motion Modality AccessoryBXB · Traditional | Sports Medical Synergy | 03/02/1992SE |
| K920380 | Jace Model W550 Wrist CPM DeviceBXB · Traditional | Jace Systems, Inc. | 02/11/1992SE |
| K914860 | Sutter Model 10000 Leg CPM DeviceBXB · Traditional | Sutter Corp. | 01/08/1992SE |
| K914394 | Back MasterBXB · Traditional | Progressive Electrical Therapeutics | 11/13/1991SE |
| K913227 | Jace Model T300 Toe CPM DeviceBXB · Traditional | Thera Kinetics, Inc. | 08/16/1991SE |
| K912537 | Jace Model K200 Knee CPM Device, ModificationBXB · Traditional | Thera Kinetics, Inc. | 08/16/1991SE |
| K912086 | Fma TranslatorBXB · Traditional | Normandie Group, Inc. | 08/07/1991SE |
| K904963 | Extend Track UnitBXB · Traditional | Anthony Chiropractic Clinic, Inc. | 06/28/1991SE |
| K905718 | RomflexBXB · Traditional | Paraflex Corp. | 02/19/1991SE |
| K904735 | Danniflex Model 500TM CPMBXB · Traditional | Buckman Co., Inc. | 01/30/1991SE |
| K910150 | Romflex Rehab Equip Extremities UnitBXB · Traditional | Dyna Flex, Intl. | 01/23/1991SE |
| K910151 | Romflex Rehab Equip Cervical Flexor UnitBXB · Traditional | Dyna Flex, Intl. | 01/18/1991SE |
| K910149 | Romflex Rehab Equip Lateral Flexion UnitBXB · Traditional | Dyna Flex, Intl. | 01/18/1991SE |
| K910026 | Ati Medical Comfort Plus CPM PadBXB · Traditional | Ati Medical, Inc. | 01/18/1991SE |
| K905299 | Romflex Rehabilitation EquipmentBXB · Traditional | Dyna Flex, Intl. | 12/31/1990SE |
| K893924 | Moto-Med Rf-Ii and PicoBXB · Traditional | Holl Meditronics, Inc. | 11/27/1990SE |
| K903851 | Club Foot CPM MachineBXB · Traditional | Smith & Nephew Richards, Inc. | 10/19/1990SE |
| K903467 | Jace Model 100 Knee CPM DeviceBXB · Traditional | Thera Kinetics, Inc. | 08/10/1990SE |
| K902707 | Model 9000 at Ankle CPM DeviceBXB · Traditional | Sutter Corp. | 07/25/1990SE |
| K902452 | Continuous Passive Motion (CPM) Leg ExerciserBXB · Traditional | Berner Assoc., Inc. | 06/11/1990SE |
| K900795 | Mobilimb L4 Lower Limb CPM UnitBXB · Traditional | Toronto Medical Corp. | 03/12/1990SE |
| K900466 | Mobilimb W1 Wrist CPM UnitBXB · Traditional | Toronto Medical Corp. | 03/12/1990SE |
| K895720 | Mobilimb J1 TMJ CPM UnitBXB · Traditional | Toronto Medical Corp. | 01/04/1990SE |
| K894907 | Mark IV Hand, Thumb and Wrist (CPM) UnitBXB · Traditional | Innovative Medical Engineering, Inc. | 10/06/1989SE |
| K895015 | Artromot(Tm) CPM DevicesBXB · Traditional | Buckman Co., Inc. | 09/11/1989SE |
| K891345 | Mobilimb CPM Shoulder UnitBXB · Traditional | Toronto Medical Corp. | 04/24/1989SE |
| K890838 | Rehabot-YmBXB · Traditional | Imex Health, Inc. | 03/23/1989SE |
| K885182 | Total Knee CPMBXB · Traditional | Invacare Corp. | 03/15/1989SE |
| K890607 | Sutter Hospital CPMBXB · Traditional | Sutter Corp. | 02/27/1989SE |
| K885095 | Supreme Toning SystemsBXB · Traditional | Supreme Toning Systems | 02/06/1989SE |
| K890200 | Pneumatic DorsiflexorBXB · Traditional | Medical Flotation Systems, Inc. | 02/03/1989SE |
| K881314 | Promo-Rist C.P.M.BXB · Traditional | Professional Motion, Inc. | 01/13/1989SE |
| K882406 | Conva-LiftBXB · Traditional | Numerical Concepts, Inc. | 11/30/1988SE |
| K882916 | Motorized Parallel Bar, Model 110BXB · Traditional | Tri W-G, Inc. | 07/28/1988SE |
| K880865 | Resubmitted Ergometer Exercise Bike Model FT1300BXB · Traditional | Invacare Corp. | 05/02/1988SE |
| K873658 | Ankle Reflex Treatment Unit (Artu)BXB · Traditional | Universal Gym Equipment, Inc. | 04/21/1988SE |
| K880092 | Resubmitted Fitness Upper Body Ergometer #5100BXB · Traditional | Invacare Corp. | 04/11/1988SE |
| K874884 | Medtronic(R) Orthoflex(Tm)BXB · Traditional | Metronic, Inc. | 01/28/1988SE |
| K872815 | Transjaw(Tm)BXB · Traditional | Vitek, Inc. | 01/19/1988SE |
| K874196 | Power Exercise EquipmentBXB · Traditional | Arc Motion , Ltd. | 12/10/1987SE |
| K872639 | Deluxe Motorized Treadmill Model #FT2300BXB · Traditional | Invacare Corp. | 09/18/1987SE |
| K872638 | Motorized Treadmill Model #FT2200BXB · Traditional | Invacare Corp. | 09/18/1987SE |
| K872586 | Ergometric Motorized Treadmill Model #FT2400BXB · Traditional | Invacare Corp. | 09/18/1987SE |
| K871981 | Bilateral Continuous Passive Motion DeviceBXB · Traditional | Avec Scientific Design Corp. | 06/17/1987SE |
| K871012 | Continuous Passive Motion Patient Kit or Re. PadBXB · Traditional | Cropper Medical, Inc. | 03/25/1987SE |
| K870402 | Mobilimb Hand ExerciserBXB · Traditional | Biodynamic Technologies, Inc. | 03/16/1987SE |
| K870510 | Danniflex 400IBXB · Traditional | Buckman Co., Inc. | 02/26/1987SE |
| K864427 | KneecpmBXB · Traditional | Invacare Corp. | 12/02/1986SE |
| K863639 | Articular Motion Device (AMD4000)BXB · Traditional | Med Surg Designs, Inc. | 09/29/1986SE |
| K862730 | Danniflex 400SLBXB · Traditional | Danninger Medical Technology, Inc. | 07/24/1986SE |
| K862093 | Gingerbread Man (TM)BXB · Traditional | Southern Pride Manufacturing, Inc. | 07/22/1986SE |
| K862314 | Hip Continuous Passive Motion MachineBXB · Traditional | Richards Medical Co., Inc. | 07/15/1986SE |
| K854354 | The Bledsoe Passive Motion ExerciserBXB · Traditional | Medical Technology and Innovations, Inc. | 02/06/1986SE |
| K852977 | Knee MachineBXB · Traditional | Kaiser Medical | 10/16/1985SE |
| K852399 | Total CPMBXB · Traditional | Invacare Corp. | 08/09/1985SE |
| K852065 | Preston Lower Limb CPM UnitBXB · Traditional | Therapeutic Equipment Corp. | 07/19/1985SE |
| K851331 | Empi Model 100, Cpm(Power Excerise Equipment)BXB · Traditional | Empi | 07/17/1985SE |
| K851177 | Universal Power FlexBXB · Traditional | Biodynamic Technologies, Inc. | 06/28/1985SE |
| K844779 | Healthmaster- Model 8320 Motorized TreadmillBXB · Traditional | Roadmaster Corp. | 06/28/1985SE |
| K850871 | Tredband Type I, It, II & III - TreadmillsBXB · Traditional | Ketronic, Inc. | 06/05/1985SE |
| K844118 | Therapeutic Limb ManipulatorBXB · Traditional | Donald E. Redding | 05/17/1985SE |
| K850332 | Kinetic 8080 Hand & Wrist Contin. Passive MachineBXB · Traditional | Richards Medical Co., Inc. | 05/01/1985SE |
| K850274 | Sutter CPM 9000 -Nonmeasuring Exercise EquipmentBXB · Traditional | Sutter Biomedical, Inc. | 04/25/1985SE |
| K850030 | Concentrical Continuous Passive Motion MachineBXB · Traditional | Arc Motion , Ltd. | 04/25/1985SE |
| K844995 | Synchro-Link -Contin-Passive Motion Device/MuscleBXB · Traditional | Cropper Medical, Inc. | 04/01/1985SE |
| K843309 | Uniflex DanningerBXB · Traditional | Buckman Co., Inc. | 10/16/1984SE |
| K843493 | Patient Guided Knee ExerciserBXB · Traditional | Richards Medical Co., Inc. | 09/12/1984SE |
| K842882 | Ankle MobilizerBXB · Traditional | Joint Mobilizer Systems, Inc. | 08/08/1984SE |
| K842881 | Knee-Hip MobilizerBXB · Traditional | Joint Mobilizer Systems, Inc. | 08/08/1984SE |
| K842433 | Allied Assoc. Therapeutic ExerciseBXB · Traditional | Allied Associates, Inc. | 08/02/1984SE |
| K842430 | Allied Assoc. Therap. Exercise EquipBXB · Traditional | Allied Associates, Inc. | 08/02/1984SE |
| K842429 | Allied Assoc. Therapeutic Exer Equip-BXB · Traditional | Allied Associates, Inc. | 08/02/1984SE |
| K842432 | Allied Associates Therapeutic ExersieBXB · Traditional | Allied Associates, Inc. | 08/01/1984SE |
| K842431 | Allied Assoc. Therap. Exercise Equip-BXB · Traditional | Allied Associates, Inc. | 08/01/1984SE |
| K842428 | Allied Assoc. Therapeutic Exercice EquipBXB · Traditional | Allied Associates, Inc. | 08/01/1984SE |
| K842427 | Allied Assoc. Therapeutic Exercise EquipBXB · Traditional | Allied Associates, Inc. | 08/01/1984SE |
| K842426 | Allied Assoc. Therapeutic ExericseBXB · Traditional | Allied Associates, Inc. | 08/01/1984SE |
| K842425 | Allied Associates Therapeutic ExerciseBXB · Traditional | Allied Associates, Inc. | 08/01/1984SE |
| K841674 | Continuous Passive MotionBXB · Traditional | Chattanooga Group, Inc. | 05/09/1984SE |
| K841413 | Hydra-Gym Athletics Inc.BXB · Traditional | Hydra Fitness Industries | 04/18/1984SE |
| K834203 | Flexxr* CPM SystemBXB · Traditional | Qarex Laboratories, Inc. | 01/30/1984SE |
| K831910 | Stryker Leg ExerciserBXB · Traditional | Stryker Corp. | 07/12/1983SE |
| K830793 | Patient Guided Elbow & Shoulder ExercBXB · Traditional | Richard'S Medical Equip., Inc. | 06/16/1983SE |
| K830316 | UniflexBXB · Traditional | Buckman Consultants | 03/24/1983SE |
| K830649 | Sutter CPM 2000BXB · Traditional | Sutter Biomedical, Inc. | 03/17/1983SE |
| K830369 | Power FlexBXB · Traditional | Biodynamic Technologies of Florida | 03/08/1983SE |
| K830122 | Continuous Anatomical Passive ExerciserBXB · Traditional | Zimmer, Inc. | 02/07/1983SE |
| K823495 | Mobilimb-Cpm Upper/Lower Limb DeviceBXB · Traditional | Synthes (Usa) | 01/21/1983SE |
| K823539 | Sutter CPMBXB · Traditional | Sutter Biomedical, Inc. | 01/14/1983SE |
| K822212 | Motorized ExerciserBXB · Traditional | W.R. Mccullin | 08/31/1982SE |
| K822031 | Autorange Model 205BXB · Traditional | Tri W-G, Inc. | 07/26/1982SE |
| K821016 | Quadruple Jogger ExerciserBXB · Traditional | Industrial Energy Specialists, Inc. | 04/26/1982SE |
| K820476 | KEM-2BXB · Traditional | Medical Graphics Corp. | 03/08/1982SE |
| K820120 | Patient Guided Knee ExerciserBXB · Traditional | Richard'S Medical Equip., Inc. | 01/29/1982SE |
| K820083 | Sutter CPMBXB · Traditional | Sutter Biomedical, Inc. | 01/28/1982SE |
| K810238 | Supine Stress SystemBXB · Traditional | O'Neill | 02/13/1981SE |
| K800007 | Work SimulatorBXB · Traditional | Baltimore Therapeutic Equipment Co. | 01/21/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3162-2024 Class II | Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting…Some power supply units in Austria and Germany had a voltage drop in the millisecond range, which led to a… | Btt Health Gmbh | 08/01/2024Open, Classified |
| Z-2135-2020 Class II | Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait -…The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light… | Motek Medical B.V. | 07/29/2019Open, Classified |
| Z-1837-2013 Class II | Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV.…An anomaly in the firmware that may cause Omnicycle Elite to operate at a speed other than what was… | Accelerated Care Plus Corporation | 06/12/2013Terminated |
| Z-0571-2013 Class II | SpineSix consists of a motorized treatment table that is controlled by an integral…BioMotion is issuing a field correction for all models of the SpineSix (SpineSix01 and SpineSix02; serial… | BioMotion Medical Systems, LLC | 11/12/2012Terminated |
| Z-3026-2011 | AlterG Anti-Gravity Treadmill; Alter G, 48349 Milmont Drive, Fremont, Ca 94538 Product…Potential installation error on AlterG Anti-Gravity Treadmill that could cause greater than expected… | Alter-G, Incorporated | 07/15/2011Terminated |
| Z-0590-2010 | Hocoma Lokomat-System with Pediatric Module Software Versions: V4.30, V4.31, V4.31a…Changes to the stored "sensitivity" values may occur and leads to higher limits in the force and trajectory… | Hocoma AG | 05/27/2009Terminated |