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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