FDA 510(k) Applications for Medical Device Product Code "BXB"
(Exerciser, Powered)

FDA 510(k) Number Applicant Device Name Decision Date
K930780 ADVANCED KINETICS, INC. ADV400 TOE CPM 02/17/1994
K842430 ALLIED ASSOCIATES, INC. ALLIED ASSOC. THERAP. EXERCISE EQUIP 08/02/1984
K842431 ALLIED ASSOCIATES, INC. ALLIED ASSOC. THERAP. EXERCISE EQUIP- 08/01/1984
K842429 ALLIED ASSOCIATES, INC. ALLIED ASSOC. THERAPEUTIC EXER EQUIP- 08/02/1984
K842428 ALLIED ASSOCIATES, INC. ALLIED ASSOC. THERAPEUTIC EXERCICE EQUIP 08/01/1984
K842433 ALLIED ASSOCIATES, INC. ALLIED ASSOC. THERAPEUTIC EXERCISE 08/02/1984
K842427 ALLIED ASSOCIATES, INC. ALLIED ASSOC. THERAPEUTIC EXERCISE EQUIP 08/01/1984
K842426 ALLIED ASSOCIATES, INC. ALLIED ASSOC. THERAPEUTIC EXERICSE 08/01/1984
K842425 ALLIED ASSOCIATES, INC. ALLIED ASSOCIATES THERAPEUTIC EXERCISE 08/01/1984
K842432 ALLIED ASSOCIATES, INC. ALLIED ASSOCIATES THERAPEUTIC EXERSIE 08/01/1984
K072887 ALTER-G, INC. G-TRAINER MEDICAL 01/25/2008
K922493 AMERICAN MEDICAL CORP. AMERICAN MEDICAL MFG. LUMBAR CPM 07/27/1992
K904963 ANTHONY CHIROPRACTIC CLINIC, INC. EXTEND TRACK UNIT 06/28/1991
K925807 AQUACISER, INC. AQUACISER IN-POOL TREADMILL 03/24/1993
K945733 AQUARIUS ELECTRONICS, INC. AQUAHAB, MODEL 120-72-101 09/15/1995
K850030 ARC MOTION LTD. CONCENTRICAL CONTINUOUS PASSIVE MOTION MACHINE 04/25/1985
K874196 ARC MOTION LTD. POWER EXERCISE EQUIPMENT 12/10/1987
K910026 ATI MEDICAL, INC. ATI MEDICAL COMFORT PLUS CPM PAD 01/18/1991
K871981 AVEC SCIENTIFIC DESIGN CORP. BILATERAL CONTINUOUS PASSIVE MOTION DEVICE 06/17/1987
K955105 BALTIMORE THERAPEUTIC EQUIPMENT CO. BTE CPM-10 12/29/1995
K955106 BALTIMORE THERAPEUTIC EQUIPMENT CO. BTE CPM-20 12/29/1995
K800007 BALTIMORE THERAPEUTIC EQUIPMENT CO. WORK SIMULATOR 01/21/1980
K902452 BERNER ASSOC., INC. CONTINUOUS PASSIVE MOTION (CPM) LEG EXERCISER 06/11/1990
K935061 BIODEX MEDICAL SYSTEMS, INC. LOWER BODY CYCLES 09/16/1994
K935216 BIODEX MEDICAL SYSTEMS, INC. SEMI-RECUMBENT CYCLES 09/16/1994
K935520 BIODEX MEDICAL SYSTEMS, INC. UPPER BODY CYCLES (110 VOLT)/(220 VOLT) 09/16/1994
K830369 BIODYNAMIC TECHNOLOGIES OF FLORIDA POWER FLEX 03/08/1983
K870402 BIODYNAMIC TECHNOLOGIES, INC. MOBILIMB HAND EXERCISER 03/16/1987
K851177 BIODYNAMIC TECHNOLOGIES, INC. UNIVERSAL POWER FLEX 06/28/1985
K950755 BREG, INC. FLEXMATE K500 10/05/1995
K924484 BUCKMAN CO., INC. ARTROMOT MULTI DIRECTIONAL ANKLE CPM 03/22/1993
K923857 BUCKMAN CO., INC. ARTROMOT SB ELBOW ATTACHMENT 02/12/1993
K895015 BUCKMAN CO., INC. ARTROMOT(TM) CPM DEVICES 09/11/1989
K870510 BUCKMAN CO., INC. DANNIFLEX 400I 02/26/1987
K923217 BUCKMAN CO., INC. DANNIFLEX CPM 2000 08/03/1992
K904735 BUCKMAN CO., INC. DANNIFLEX MODEL 500TM CPM 01/30/1991
K923216 BUCKMAN CO., INC. DANNINFLEX CPM 800 08/03/1992
K843309 BUCKMAN CO., INC. UNIFLEX DANNINGER 10/16/1984
K830316 BUCKMAN CONSULTANTS UNIFLEX 03/24/1983
K841674 CHATTANOOGA GROUP, INC. CONTINUOUS PASSIVE MOTION 05/09/1984
K871012 CROPPER MEDICAL, INC. CONTINUOUS PASSIVE MOTION PATIENT KIT OR RE. PAD 03/25/1987
K844995 CROPPER MEDICAL, INC. SYNCHRO-LINK -CONTIN-PASSIVE MOTION DEVICE/MUSCLE 04/01/1985
K931128 DANNINGER MEDICAL TECHNOLOGY, INC. BASIC SHOULDER CPM 05/06/1994
K862730 DANNINGER MEDICAL TECHNOLOGY, INC. DANNIFLEX 400SL 07/24/1986
K933394 DANNINGER MEDICAL TECHNOLOGY, INC. DANNIFLEX CPM 600 03/11/1994
K003272 DISCOVERY GROUP LLC. FLO-BOOT 04/04/2001
K844118 DONALD E. REDDING THERAPEUTIC LIMB MANIPULATOR 05/17/1985
K910151 DYNA FLEX, INTL. ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT 01/18/1991
K910150 DYNA FLEX, INTL. ROMFLEX REHAB EQUIP EXTREMITIES UNIT 01/23/1991
K910149 DYNA FLEX, INTL. ROMFLEX REHAB EQUIP LATERAL FLEXION UNIT 01/18/1991
K905299 DYNA FLEX, INTL. ROMFLEX REHABILITATION EQUIPMENT 12/31/1990
K925043 ELECTROBIONICS CORP. ELBOW CPM ORTHOSIS 02/12/1993
K851331 EMPI EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT) 07/17/1985
K945690 ERGOMEDICS, INC. BACKCYCLER CPM(TM) 06/22/1995
K935509 FERNO ILLE HYDROTRACK 10/03/1994
K953456 FLUID MOTION BIOTECHNOLOGIES, INC. E-Z FLEX 01/26/1996
K945824 GALAXY AQUATICS, INC. GALAXY MD SERIES THERAPYPOOLS 04/05/1995
K926313 HENLEY INTL. COMPUTERIZED TESTING AND EXERCISE SYSTEMS 02/04/1994
K893924 HOLL MEDITRONICS, INC. MOTO-MED "RF-II" AND "PICO" 11/27/1990
K841413 HYDRA FITNESS INDUSTRIES HYDRA-GYM ATHLETICS INC. 04/18/1984
K890838 IMEX HEALTH, INC. REHABOT-YM 03/23/1989
K821016 INDUSTRIAL ENERGY SPECIALISTS, INC. QUADRUPLE JOGGER EXERCISER 04/26/1982
K894907 INNOVATIVE MEDICAL ENGINEERING, INC. "MARK IV" HAND, THUMB AND WRIST (CPM) UNIT 10/06/1989
K872639 INVACARE CORP. DELUXE MOTORIZED TREADMILL MODEL #FT2300 09/18/1987
K872586 INVACARE CORP. ERGOMETRIC MOTORIZED TREADMILL MODEL #FT2400 09/18/1987
K864427 INVACARE CORP. KNEECPM 12/02/1986
K872638 INVACARE CORP. MOTORIZED TREADMILL MODEL #FT2200 09/18/1987
K880865 INVACARE CORP. RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300 05/02/1988
K880092 INVACARE CORP. RESUBMITTED FITNESS UPPER BODY ERGOMETER #5100 04/11/1988
K852399 INVACARE CORP. TOTAL CPM 08/09/1985
K885182 INVACARE CORP. TOTAL KNEE CPM 03/15/1989
K933059 JACE SYSTEMS, INC. ARTROMOT-E, ELBOW / ARTROMOT-S, SHOULDER CMP MOD. 06/22/1994
K922185 JACE SYSTEMS, INC. JACE KNEE EXTENSION SYSTEM -- MODIFICATION 06/11/1992
K920380 JACE SYSTEMS, INC. JACE MODEL W550 WRIST CPM DEVICE 02/11/1992
K842882 JOINT MOBILIZER SYSTEMS, INC. ANKLE MOBILIZER 08/08/1984
K842881 JOINT MOBILIZER SYSTEMS, INC. KNEE-HIP MOBILIZER 08/08/1984
K852977 KAISER MEDICAL KNEE MACHINE 10/16/1985
K850871 KETRONIC, INC. TREDBAND TYPE I, IT, II & III - TREADMILLS 06/05/1985
K925666 KVM TECHNOLOGIES, INC. THERAPACER 3000 03/09/1993
K921348 LM PRODUCT DESIGN, INC. OIC MODEL J4 TMJ CPM 08/05/1992
K924513 LOREDAN BIOMEDICAL, INC. LIDO(R) LINEA 03/31/1993
K863639 MED SURG DESIGNS, INC. ARTICULAR MOTION DEVICE (AMD4000) 09/29/1986
K890200 MEDICAL FLOTATION SYSTEMS, INC. PNEUMATIC DORSIFLEXOR 02/03/1989
K820476 MEDICAL GRAPHICS CORP. KEM-2 03/08/1982
K931736 MEDICAL SYSTEMS CORP. M-FLEX 5000 C3PMD 01/27/1994
K854354 MEDICAL TECHNOLOGY AND INNOVATIONS, INC. THE BLEDSOE PASSIVE MOTION EXERCISER 02/06/1986
K874884 METRONIC, INC. MEDTRONIC(R) ORTHOFLEX(TM) 01/28/1988
K933311 MIDLAND MFG. CO. MOTORIZED ELECTRIC PARALLEL BARS 01/26/1994
K912086 NORMANDIE GROUP, INC. FMA TRANSLATOR 08/07/1991
K946169 NORTH ATLANTIC REHABILITATION, INC, ACTIC 2002 06/15/1995
K951029 NORTHERN ORTHOPAEDIC PRODUCTS, INC. HAMEX ONE 09/15/1995
K951028 NORTHERN ORTHOPAEDIC PRODUCTS, INC. HAMEX TWO 12/11/1995
K923805 NOVA TEKNIC, INC. POWER PILLOW 02/12/1993
K882406 NUMERICAL CONCEPTS, INC. CONVA-LIFT 11/30/1988
K810238 O'NEILL SUPINE STRESS SYSTEM 02/13/1981
K931555 ORMED MFG., INC. ARTROMOT K2 CPM 01/31/1994
K935188 ORTHOPEDIC DEVELOPMENT, INC. STRETCHPOWER 03/24/1994
K934175 ORTHOPEDIC DEVELOPMENT, INC. STRETCHPOWER(TM) BRAND OF STRETCH LOADING EXERCISER 03/24/1994
K941128 OSTEONICS CORP. OSTEONICS SERIES 7000 BASIC FEMORAL COMPONENTS 12/08/1994
K905718 PARAFLEX CORP. ROMFLEX 02/19/1991
K923494 PARAMED DIV PARAMED LATERAL FLEXION MACHINE 11/09/1992
K925977 PARAMED SERVICES, INC. PARAMED FLEXION-EXTENSION MACHINE 03/31/1993
K952369 PHYSICIANS CONSULTING, INC. KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLE 08/07/1995
K944819 PHYSICIANS CONSULTING, INC. KRDL 2000 03/10/1995
K920686 PLEXUS INTL., INC. ORTHO-PLEX-REHABILITATION SYSTEM 06/11/1992
K942618 PREVENT PRODUCTS, INC. ANKLE CALF EXERCISER 06/22/1994
K952975 PREVENT PRODUCTS, INC. ANKLE CALF EXERCISER PHLEBOPUMP 09/25/1996
K881314 PROFESSIONAL MOTION, INC. PROMO-RIST C.P.M. 01/13/1989
K914394 PROGRESSIVE ELECTRICAL THERAPEUTICS BACK MASTER 11/13/1991
K834203 QAREX LABORATORIES, INC. FLEXXR* CPM SYSTEM 01/30/1984
K935467 R & D BATTERIES, INC. R & D BATTERIES, INC. PART NUMBER 5447 04/19/1994
K940455 REHAB, INC. LATERAL FLEXION MACHINE 01/12/1995
K921323 REHABILITATIVE RESOURCES, INC. CERVICAL PASSIVE MOTION 06/03/1992
K920519 REHABILITATIVE RESOURCES, INC. LUMBAR CPM 03/13/1992
K925271 REPEX INTL., INC. REPEX-REPEATED ENDRANGE PASSIVE EXERCISE MACHINE 03/31/1993
K830793 RICHARD'S MEDICAL EQUIP., INC. PATIENT GUIDED ELBOW & SHOULDER EXERC 06/16/1983
K820120 RICHARD'S MEDICAL EQUIP., INC. PATIENT GUIDED KNEE EXERCISER 01/29/1982
K862314 RICHARDS MEDICAL CO., INC. HIP CONTINUOUS PASSIVE MOTION MACHINE 07/15/1986
K850332 RICHARDS MEDICAL CO., INC. KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE 05/01/1985
K843493 RICHARDS MEDICAL CO., INC. PATIENT GUIDED KNEE EXERCISER 09/12/1984
K844779 ROADMASTER CORP. HEALTHMASTER- MODEL 8320 MOTORIZED TREADMILL 06/28/1985
K931723 SANTA FE SWIM SYSTEMS HYDRO-TRED/AIR POWERED TREADMILL 01/26/1994
K926262 SGARLATO LABORATORIES, INC. FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE 01/26/1994
K903851 SMITH & NEPHEW RICHARDS, INC. CLUB FOOT CPM MACHINE 10/19/1990
K862093 SOUTHERN PRIDE MANUFACTURING, INC. GINGERBREAD MAN (TM) 07/22/1986
K920270 SPORTS MEDICAL SYNERGY CONTINUOUS PASSIVE MOTION MODALITY ACCESSORY 03/02/1992
K831910 STRYKER CORP. STRYKER LEG EXERCISER 07/12/1983
K885095 SUPREME TONING SYSTEMS SUPREME TONING SYSTEMS 02/06/1989
K820083 SUTTER BIOMEDICAL, INC. SUTTER CPM 01/28/1982
K823539 SUTTER BIOMEDICAL, INC. SUTTER CPM 01/14/1983
K830649 SUTTER BIOMEDICAL, INC. SUTTER CPM 2000 03/17/1983
K850274 SUTTER BIOMEDICAL, INC. SUTTER CPM 9000 -NONMEASURING EXERCISE EQUIPMENT 04/25/1985
K924654 SUTTER CORP. FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT 02/22/1993
K902707 SUTTER CORP. MODEL 9000 AT ANKLE CPM DEVICE 07/25/1990
K890607 SUTTER CORP. SUTTER HOSPITAL CPM 02/27/1989
K914860 SUTTER CORP. SUTTER MODEL 10000 LEG CPM DEVICE 01/08/1992
K945221 SUTTER CORP. SUTTER MODEL 6000 HAND CPM DEVICE 02/27/1995
K935011 SWIMEX SYSTEMS SWIMEX MULTIDEPTH POOL (MODEL 600T) 01/09/1995
K823495 SYNTHES (USA) MOBILIMB-CPM UPPER/LOWER LIMB DEVICE 01/21/1983
K925270 TECOGICS SCIENTIFIC LTD. EX N' FLEX EF-200 07/21/1993
K903467 THERA KINETICS, INC. JACE MODEL 100 KNEE CPM DEVICE 08/10/1990
K912537 THERA KINETICS, INC. JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION 08/16/1991
K913227 THERA KINETICS, INC. JACE MODEL T300 TOE CPM DEVICE 08/16/1991
K852065 THERAPEUTIC EQUIPMENT CORP. PRESTON LOWER LIMB CPM UNIT 07/19/1985
K891345 TORONTO MEDICAL CORP. MOBILIMB CPM SHOULDER UNIT 04/24/1989
K895720 TORONTO MEDICAL CORP. MOBILIMB J1 TMJ CPM UNIT 01/04/1990
K900795 TORONTO MEDICAL CORP. MOBILIMB L4 LOWER LIMB CPM UNIT 03/12/1990
K925926 TORONTO MEDICAL CORP. MOBILIMB T1 TOE CPM UNIT 03/22/1993
K900466 TORONTO MEDICAL CORP. MOBILIMB W1 WRIST CPM UNIT 03/12/1990
K935587 TORONTO MEDICAL CORP. MULTILINK SHOULDER CPM UNIT 12/14/1994
K950682 TORONTO MEDICAL CORP. W2 WRIST CPM UNIT 09/13/1995
K945121 TORONTO MEDICAL, INC. A3 ANKLE CPM UNIT 02/17/1995
K935808 TORONTO MEDICAL, INC. REVOLUTION LOWER LIMB CPM UNIT 03/18/1994
K822031 TRI W-G, INC. AUTORANGE MODEL 205 07/26/1982
K882916 TRI W-G, INC. MOTORIZED PARALLEL BAR, MODEL 110 07/28/1988
K920860 U.S. MFG. & MANAGEMENT, INC. CONTROLLED PASSIVE MOTION MACHINE 04/02/1992
K873658 UNIVERSAL GYM EQUIPMENT, INC. ANKLE REFLEX TREATMENT UNIT (ARTU) 04/21/1988
K872815 VITEK, INC. TRANSJAW(TM) 01/19/1988
K822212 W.R. MCCULLIN "MOTORIZED EXERCISER 08/31/1982
K926136 WATSYSTEM DIV. OF ITC WATSYSTEM 05/20/1994
K830122 ZIMMER, INC. CONTINUOUS ANATOMICAL PASSIVE EXERCISER 02/07/1983


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